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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00153062




Registration number
NCT00153062
Ethics application status
Date submitted
9/09/2005
Date registered
12/09/2005
Date last updated
13/05/2014

Titles & IDs
Public title
PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes
Scientific title
PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes: A Double-blind, Active and Placebo Controlled Study of Aggrenox vs. Clopidogrel, With and Without Micardis
Secondary ID [1] 0 0
9.159
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Aggrenox
Treatment: Drugs - Aggrenox
Treatment: Drugs - Clopidogrel placebo
Treatment: Drugs - Clopidogrel placebo
Treatment: Drugs - Micardis
Treatment: Drugs - Micardis
Treatment: Drugs - Aggrenox placebo
Treatment: Drugs - Aggrenox placebo
Treatment: Drugs - Clopidogrel
Treatment: Drugs - Clopidogrel
Treatment: Drugs - Micardis placebo
Treatment: Drugs - Micardis placebo

Placebo Comparator: Aggrenox, Clopidogrel placebo, Micardis - Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis (80mg) qd

Placebo Comparator: Aggrenox placebo, clopidogrel,, Micardis - Clopidogrel (75mg) qd; Aggrenox placebo bid, Micardis (80mg) qd

Placebo Comparator: Aggrenox, clop placebo, micardis placebo - Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis placebo qd

Placebo Comparator: Aggrenox plcebo, clop, micardis placebo - Clopidogrel (75mg) qd, Aggrenox placebo bid, Micardis placebo qd.


Treatment: Drugs: Aggrenox
25mg aspirin, 200 mg dipyridamole

Treatment: Drugs: Aggrenox
25mg aspirin, 200 mg dipyridamole

Treatment: Drugs: Clopidogrel placebo
placebo

Treatment: Drugs: Clopidogrel placebo
placebo

Treatment: Drugs: Micardis
80 mg micardis

Treatment: Drugs: Micardis
80 mg micardis

Treatment: Drugs: Aggrenox placebo
placebo

Treatment: Drugs: Aggrenox placebo
placebo

Treatment: Drugs: Clopidogrel
75 mg clopidogrel

Treatment: Drugs: Clopidogrel
75 mg clopidogrel

Treatment: Drugs: Micardis placebo
placebo

Treatment: Drugs: Micardis placebo
placebo

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only)
Timepoint [1] 0 0
time since randomization; follow-up period is 1.5 to 4.4 years
Primary outcome [2] 0 0
Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only)
Timepoint [2] 0 0
time since randomization; follow-up period is 1.5 to 4.4 years
Secondary outcome [1] 0 0
Composite Outcome of Stroke, Myocardial Infarction (MI), or Vascular Death (Antiplatelet Comparison Only) - Number of patients with any of stroke, myocardial infarction, vascular death
Timepoint [1] 0 0
time since randomization; follow-up period is 1.5 to 4.4 years
Secondary outcome [2] 0 0
Composite Outcome of Stroke, Myocardial Infarction, Vascular Death, or New or Worsening Congestive Heart Failure (CHF) (Telmisartan vs. Placebo Only) - Number of patients with any of stroke, myocardial infarction, vascular death, or new or worsening congestive heart failure
Timepoint [2] 0 0
time since randomization; follow-up period is 1.5 to 4.4 years
Secondary outcome [3] 0 0
Number of Patients With New Onset of Diabetes (Telmisartan vs. Placebo Only)
Timepoint [3] 0 0
Randomization to final patient contact

Eligibility
Key inclusion criteria
Inclusion criteria:

Male or female subjects 55 year or older who have suffered an ischemic stroke within the
past 90 days and who meet all other inclusion criteria. Include also patients of ages 50 -
54 years and/or 90 to 120 days after the qualifying stroke provided the patient has at
least two of the following additional risk factors:

- Diabetes mellitus

- Hypertension (systolic BP ¿ 140 or diastolic BP ¿ 90)

- Smoker at time of qualifying stroke

- Obesity (BMI>30; BMI=weight (kg)/[height (m)]2)

- Previous vascular disease (stroke, MI, or peripheral arterial disease prior to
qualifying stroke)

- End-organ-damage (retinopathy, LVH, or microalbuminuria)

- Hyperlipidemia
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

hemorrhagic stroke (must be ruled out by imaging);unable to give informed consent; known
brain tumor, severe renal or hepatic insufficiency, current active peptic ulcer disease,
severe coronary artery disease including unstable angina pectoris or an MI within the
previous 3 months,or history of a hemostatic disorder or systemic bleeding
;hyperkalemia;uncorrected volume or sodium depletion; pre-stroke history of
dementia;modified Rankin score greater than 4;qualifying stroke induced by surgical or
cardiovascular procedure;uncontrolled hypertension at entry above 180/110 mmHg (goal BPs
are lower); SBP 120 mmHg or less for hospitalized patients; currently taking an ARB and not
able or willing to switch to alternative; required or planned continuing treatment with
antithrombotics or anticoagulants including heparin or warfarin or non-study platelet
inhibitors; syndrome of asthma, rhinitis and nasal polyps;scheduled for major surgery,
carotid endarterectomy, or carotid angioplasty (4 weeks post surgery is allowed);unlikely
to be released from hospital following the qualifying stroke or presence of a severe
disability likely to lead to being bedridden or demented or a non-vascular disease or
condition which makes it unlikely that the patient will survive to the end of the trial;
history of thrombocytopenia or neutropenia.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
9.159.2444 Boehringer Ingelheim Investigational Site - Gosford
Recruitment hospital [2] 0 0
9.159.2449 Boehringer Ingelheim Investigational Site - New Lambton
Recruitment hospital [3] 0 0
9.159.2448 Boehringer Ingelheim Investigational Site - Westmead
Recruitment hospital [4] 0 0
9.159.2450 Boehringer Ingelheim Investigational Site - Herston
Recruitment hospital [5] 0 0
9.159.2452 Boehringer Ingelheim Investigational Site - Southport
Recruitment hospital [6] 0 0
9.159.2451 Boehringer Ingelheim Investigational Site - Bedford Park
Recruitment hospital [7] 0 0
9.159.2443 Boehringer Ingelheim Investigational Site - Box Hill
Recruitment hospital [8] 0 0
9.159.2447 Boehringer Ingelheim Investigational Site - Melbourne
Recruitment hospital [9] 0 0
9.159.2445 Boehringer Ingelheim Investigational Site - Parkville
Recruitment hospital [10] 0 0
9.159.2446 Boehringer Ingelheim Investigational Site - West Heidelberg
Recruitment postcode(s) [1] 0 0
- Gosford
Recruitment postcode(s) [2] 0 0
- New Lambton
Recruitment postcode(s) [3] 0 0
- Westmead
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- Herston
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- Southport
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- Bedford Park
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- Box Hill
Recruitment postcode(s) [8] 0 0
- Melbourne
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- Parkville
Recruitment postcode(s) [10] 0 0
- West Heidelberg
Recruitment outside Australia
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Vibo Valentia
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Italy
State/province [205] 0 0
Vicenza
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Japan
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Adachi-ku, Tokyo
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Japan
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Japan
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Ako, Hyogo
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Japan
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Aoba-ku, Yokohama, Kanagawa
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Japan
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Azumino, Nagano
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Japan
State/province [211] 0 0
Chitose, Hokkaido
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Japan
State/province [212] 0 0
Chuo-ku, Kobe, Hyogo
Country [213] 0 0
Japan
State/province [213] 0 0
Chuo-Ku, Sapporo, Hokkaido
Country [214] 0 0
Japan
State/province [214] 0 0
Fushimi-ku, Kyoto, Kyoto
Country [215] 0 0
Japan
State/province [215] 0 0
Habikino, Osaka
Country [216] 0 0
Japan
State/province [216] 0 0
Higashi-ku, Sapporo, Hokkaido
Country [217] 0 0
Japan
State/province [217] 0 0
Higashi-osaka, Osaka
Country [218] 0 0
Japan
State/province [218] 0 0
Higashinari-ku, Osaka, Osaka
Country [219] 0 0
Japan
State/province [219] 0 0
Higashiyodogawa-ku, Osaka, Osaka
Country [220] 0 0
Japan
State/province [220] 0 0
Hitachinaka, Ibaraki
Country [221] 0 0
Japan
State/province [221] 0 0
Iida, Nagano
Country [222] 0 0
Japan
State/province [222] 0 0
Izumisano, Osaka
Country [223] 0 0
Japan
State/province [223] 0 0
Jyonan-ku, Fukuoka, Fukuoka
Country [224] 0 0
Japan
State/province [224] 0 0
Kasama, Ibaraki
Country [225] 0 0
Japan
State/province [225] 0 0
Kasuga, Fukuoka
Country [226] 0 0
Japan
State/province [226] 0 0
Kita-ku, Osaka, Osaka
Country [227] 0 0
Japan
State/province [227] 0 0
Koriyama, Fukushima
Country [228] 0 0
Japan
State/province [228] 0 0
Kushiro, Hokkaido
Country [229] 0 0
Japan
State/province [229] 0 0
Matsumoto, Nagano
Country [230] 0 0
Japan
State/province [230] 0 0
Midori-ku, Yokohama, Kanagawa
Country [231] 0 0
Japan
State/province [231] 0 0
Moriya, Ibaraki
Country [232] 0 0
Japan
State/province [232] 0 0
Musashino, Tokyo
Country [233] 0 0
Japan
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Nakagawa-ku, Nagoya, Aichi
Country [234] 0 0
Japan
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Nishi-yodogawa-ku, Osaka, Osaka
Country [235] 0 0
Japan
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Ohnojo, Fukuoka
Country [236] 0 0
Japan
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Sakai-ku, Sakai, Osaka
Country [237] 0 0
Japan
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Sawara-ku, Fukuoka, Fukuoka
Country [238] 0 0
Japan
State/province [238] 0 0
Shimogyo-ku, Kyoto, Kyoto
Country [239] 0 0
Japan
State/province [239] 0 0
Shiroishi, Miyagi
Country [240] 0 0
Japan
State/province [240] 0 0
Suwa, Nagano
Country [241] 0 0
Japan
State/province [241] 0 0
Takikawa, Hokkaido
Country [242] 0 0
Japan
State/province [242] 0 0
Tatebayashi, Gunma
Country [243] 0 0
Japan
State/province [243] 0 0
Tsuchiura, Ibaraki
Country [244] 0 0
Japan
State/province [244] 0 0
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Country [245] 0 0
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Gwangju
Country [246] 0 0
Korea, Republic of
State/province [246] 0 0
Incheon
Country [247] 0 0
Korea, Republic of
State/province [247] 0 0
Kyunggi-do
Country [248] 0 0
Korea, Republic of
State/province [248] 0 0
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Country [249] 0 0
Korea, Republic of
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Suwon
Country [250] 0 0
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State/province [250] 0 0
Kelantan Darul Naim
Country [251] 0 0
Malaysia
State/province [251] 0 0
Kuala Lumpur
Country [252] 0 0
Mexico
State/province [252] 0 0
Metepec
Country [253] 0 0
Netherlands
State/province [253] 0 0
's-Hertogenbosch
Country [254] 0 0
Netherlands
State/province [254] 0 0
Alkmaar
Country [255] 0 0
Netherlands
State/province [255] 0 0
Assen
Country [256] 0 0
Netherlands
State/province [256] 0 0
Blaricum
Country [257] 0 0
Netherlands
State/province [257] 0 0
Breda
Country [258] 0 0
Netherlands
State/province [258] 0 0
Den Haag
Country [259] 0 0
Netherlands
State/province [259] 0 0
Eindhoven
Country [260] 0 0
Netherlands
State/province [260] 0 0
Emmen
Country [261] 0 0
Netherlands
State/province [261] 0 0
Enschede
Country [262] 0 0
Netherlands
State/province [262] 0 0
Groningen
Country [263] 0 0
Netherlands
State/province [263] 0 0
Heerlen
Country [264] 0 0
Netherlands
State/province [264] 0 0
Helmond
Country [265] 0 0
Netherlands
State/province [265] 0 0
Hengelo
Country [266] 0 0
Netherlands
State/province [266] 0 0
Leeuwarden
Country [267] 0 0
Netherlands
State/province [267] 0 0
Leiderdorp
Country [268] 0 0
Netherlands
State/province [268] 0 0
Nieuwegein
Country [269] 0 0
Netherlands
State/province [269] 0 0
Nijmegen
Country [270] 0 0
Netherlands
State/province [270] 0 0
Tilburg
Country [271] 0 0
Netherlands
State/province [271] 0 0
Veldhoven
Country [272] 0 0
Netherlands
State/province [272] 0 0
Weert
Country [273] 0 0
Norway
State/province [273] 0 0
Bergen
Country [274] 0 0
Norway
State/province [274] 0 0
Oslo
Country [275] 0 0
Norway
State/province [275] 0 0
Trondheim
Country [276] 0 0
Portugal
State/province [276] 0 0
Amadora
Country [277] 0 0
Portugal
State/province [277] 0 0
Coimbra
Country [278] 0 0
Portugal
State/province [278] 0 0
Lisboa
Country [279] 0 0
Portugal
State/province [279] 0 0
Porto
Country [280] 0 0
Russian Federation
State/province [280] 0 0
Ekaterinburg
Country [281] 0 0
Russian Federation
State/province [281] 0 0
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Russian Federation
State/province [282] 0 0
Kemerovo
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Russian Federation
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Kirov
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Russian Federation
State/province [284] 0 0
Krasnoyarsk
Country [285] 0 0
Russian Federation
State/province [285] 0 0
Moscow
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Russian Federation
State/province [286] 0 0
Nizhnyi Novgorod
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Russian Federation
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Russian Federation
State/province [288] 0 0
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Country [289] 0 0
Russian Federation
State/province [289] 0 0
Orel
Country [290] 0 0
Russian Federation
State/province [290] 0 0
Rostov-na-Donu
Country [291] 0 0
Russian Federation
State/province [291] 0 0
Samara
Country [292] 0 0
Russian Federation
State/province [292] 0 0
Saratov
Country [293] 0 0
Russian Federation
State/province [293] 0 0
Seversk
Country [294] 0 0
Russian Federation
State/province [294] 0 0
Smolensk
Country [295] 0 0
Russian Federation
State/province [295] 0 0
St. Petersburg
Country [296] 0 0
Russian Federation
State/province [296] 0 0
Ufa
Country [297] 0 0
Russian Federation
State/province [297] 0 0
Volgograd
Country [298] 0 0
Russian Federation
State/province [298] 0 0
Voronezh
Country [299] 0 0
Russian Federation
State/province [299] 0 0
Yaroslavl
Country [300] 0 0
Singapore
State/province [300] 0 0
Singapore
Country [301] 0 0
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State/province [301] 0 0
Bloemfontein
Country [302] 0 0
South Africa
State/province [302] 0 0
Cape Town
Country [303] 0 0
South Africa
State/province [303] 0 0
Durban
Country [304] 0 0
South Africa
State/province [304] 0 0
Johannesburg
Country [305] 0 0
South Africa
State/province [305] 0 0
Pretoria
Country [306] 0 0
South Africa
State/province [306] 0 0
Sunninghill
Country [307] 0 0
Spain
State/province [307] 0 0
Alicante
Country [308] 0 0
Spain
State/province [308] 0 0
Barcelona
Country [309] 0 0
Spain
State/province [309] 0 0
Hospitalet de Llobregat (Barcelona)
Country [310] 0 0
Spain
State/province [310] 0 0
Madrid
Country [311] 0 0
Spain
State/province [311] 0 0
Pamplona
Country [312] 0 0
Sweden
State/province [312] 0 0
Borås
Country [313] 0 0
Sweden
State/province [313] 0 0
Eskilstuna
Country [314] 0 0
Sweden
State/province [314] 0 0
Göteborg
Country [315] 0 0
Sweden
State/province [315] 0 0
Holon
Country [316] 0 0
Sweden
State/province [316] 0 0
Jönköping
Country [317] 0 0
Sweden
State/province [317] 0 0
Lund
Country [318] 0 0
Sweden
State/province [318] 0 0
Mora
Country [319] 0 0
Sweden
State/province [319] 0 0
Skellefteå
Country [320] 0 0
Sweden
State/province [320] 0 0
Skövde
Country [321] 0 0
Sweden
State/province [321] 0 0
Stockholm
Country [322] 0 0
Sweden
State/province [322] 0 0
Umeå
Country [323] 0 0
Sweden
State/province [323] 0 0
Värnamo
Country [324] 0 0
Sweden
State/province [324] 0 0
Västervik
Country [325] 0 0
Sweden
State/province [325] 0 0
Örebro
Country [326] 0 0
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State/province [326] 0 0
Kaohsiung
Country [327] 0 0
Taiwan
State/province [327] 0 0
Taichung
Country [328] 0 0
Taiwan
State/province [328] 0 0
Tainan
Country [329] 0 0
Taiwan
State/province [329] 0 0
Taipei
Country [330] 0 0
Taiwan
State/province [330] 0 0
Taoyuan
Country [331] 0 0
Thailand
State/province [331] 0 0
Bangkok
Country [332] 0 0
Thailand
State/province [332] 0 0
Chiang Mai
Country [333] 0 0
Turkey
State/province [333] 0 0
Ankara
Country [334] 0 0
Turkey
State/province [334] 0 0
Antalya
Country [335] 0 0
Turkey
State/province [335] 0 0
Bursa
Country [336] 0 0
Turkey
State/province [336] 0 0
Eskisehir
Country [337] 0 0
Turkey
State/province [337] 0 0
Istanbul
Country [338] 0 0
Turkey
State/province [338] 0 0
Izmir
Country [339] 0 0
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State/province [339] 0 0
Dnepropetrovsk
Country [340] 0 0
Ukraine
State/province [340] 0 0
Kharkiv
Country [341] 0 0
Ukraine
State/province [341] 0 0
Kyiv
Country [342] 0 0
Ukraine
State/province [342] 0 0
Odesa
Country [343] 0 0
Ukraine
State/province [343] 0 0
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Country [344] 0 0
Ukraine
State/province [344] 0 0
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Country [345] 0 0
United Kingdom
State/province [345] 0 0
Belfast
Country [346] 0 0
United Kingdom
State/province [346] 0 0
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Country [347] 0 0
United Kingdom
State/province [347] 0 0
Bournemouth
Country [348] 0 0
United Kingdom
State/province [348] 0 0
Bristol
Country [349] 0 0
United Kingdom
State/province [349] 0 0
Dundee
Country [350] 0 0
United Kingdom
State/province [350] 0 0
Exeter
Country [351] 0 0
United Kingdom
State/province [351] 0 0
Glasgow
Country [352] 0 0
United Kingdom
State/province [352] 0 0
Harrow
Country [353] 0 0
United Kingdom
State/province [353] 0 0
Henshingham, Whitehaven
Country [354] 0 0
United Kingdom
State/province [354] 0 0
Leicester
Country [355] 0 0
United Kingdom
State/province [355] 0 0
Liverpool
Country [356] 0 0
United Kingdom
State/province [356] 0 0
London
Country [357] 0 0
United Kingdom
State/province [357] 0 0
Mansfield
Country [358] 0 0
United Kingdom
State/province [358] 0 0
Newcastle Upon Tyne
Country [359] 0 0
United Kingdom
State/province [359] 0 0
North Shields
Country [360] 0 0
United Kingdom
State/province [360] 0 0
Northampton
Country [361] 0 0
United Kingdom
State/province [361] 0 0
Nottingham
Country [362] 0 0
United Kingdom
State/province [362] 0 0
Poole
Country [363] 0 0
United Kingdom
State/province [363] 0 0
Rotherham
Country [364] 0 0
United Kingdom
State/province [364] 0 0
Sheffield
Country [365] 0 0
United Kingdom
State/province [365] 0 0
Southampton
Country [366] 0 0
United Kingdom
State/province [366] 0 0
Stoke on Trent
Country [367] 0 0
United Kingdom
State/province [367] 0 0
Sunderland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
GlaxoSmithKline
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Bayer
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the trial is to determine if extended-release dipyridamole + aspirin
[Aggrenox, Asasa ntin] is superior to clopidogrel [Plavix], and if telmisartan [Micardis,
Gliosartan, Kinzal, Kinzalm ono, Predxal, Pritor, Samertan, Telmisartan] is superior to
placebo, in the presence of background antihypertensive therapy, in prevention of a second
stroke in patients who have recently suffered a stroke and therefore are at high risk of
suffering another one.
Trial website
https://clinicaltrials.gov/show/NCT00153062
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications