Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03252249




Registration number
Help: Registration number
NCT03252249
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
9/08/2017
Date registered
Help: Date registered
17/08/2017
Date last updated
Help: Date last updated
3/11/2026

Titles & IDs
Public title
Duration of Dual Anti-Platelet Therapy (DUAL-ACS)
Scientific title
Duration of Dual Anti-Platelet Therapy in Acute Coronary Syndrome
Additional trial identifiers [1] 0 0
AC16104
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Acute Coronary Syndrome 0 0
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Other interventions - 3 months dual anti-platelet therapy
Other interventions - 12 months dual anti-platelet therapy

Active comparator: 3 months dual anti-platelet therapy - 3 months dual anti-platelet therapy.

Active comparator: 12 months dual anti-platelet therapy - 12 months dual anti-platelet therapy.


Other interventions: 3 months dual anti-platelet therapy
Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.

Other interventions: 12 months dual anti-platelet therapy
Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Intervention code [1] 0 0
Other interventions
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
Time-to-event: All-cause Mortality
Timepoint [1] 0 0
Date of index MI to 15 months
Primary outcome [2] 0 0
Incidence: All-cause Mortality
Timepoint [2] 0 0
Date of index MI to 15 months
Secondary outcome [1] 0 0
Time-to-event: Non-cardiovascular Death (Including Fatal Bleeding) and Major Non-fatal Bleeding
Timepoint [1] 0 0
Date of MI to 15 months
Secondary outcome [2] 0 0
Incidence: Non-cardiovascular Death (Including Fatal Bleeding) and Major Non-fatal Bleeding
Timepoint [2] 0 0
Date of MI to 15 months
Secondary outcome [3] 0 0
Time-to-event: Non-cardiovascular Death (Including Fatal Bleeding)
Timepoint [3] 0 0
Date of MI to 15 months
Secondary outcome [4] 0 0
Incidence: Non-cardiovascular Death (Including Fatal Bleeding)
Timepoint [4] 0 0
Date of MI to 15 months
Secondary outcome [5] 0 0
Time-to-event: Major Fatal and Non-fatal Bleeding
Timepoint [5] 0 0
Date of MI to 15 months
Secondary outcome [6] 0 0
Incidence: Major Fatal and Non-fatal Bleeding
Timepoint [6] 0 0
Date of MI to 15 months
Secondary outcome [7] 0 0
Time-to-event: Gastrointestinal Bleeding
Timepoint [7] 0 0
Date of MI to 15 months
Secondary outcome [8] 0 0
Incidence: Gastrointestinal Bleeding
Timepoint [8] 0 0
Date of MI to 15 months
Secondary outcome [9] 0 0
Time-to-event: Cardiovascular Death and Non-fatal Myocardial Infarction
Timepoint [9] 0 0
Date of MI to 15 months
Secondary outcome [10] 0 0
Incidence: Cardiovascular Death and Non-fatal Myocardial Infarction
Timepoint [10] 0 0
Date of MI to 15 months
Secondary outcome [11] 0 0
Time-to-event: Cardiovascular Mortality (Cardiac and Non-cardiac)
Timepoint [11] 0 0
Date of MI to 15 months
Secondary outcome [12] 0 0
Incidence: Cardiovascular Mortality (Cardiac and Non-cardiac)
Timepoint [12] 0 0
Date of MI to 15 months
Secondary outcome [13] 0 0
Time-to-event: Myocardial Infarction (Fatal and Non-fatal)
Timepoint [13] 0 0
Date of MI to 15 months
Secondary outcome [14] 0 0
Incidence: Myocardial Infarction (Fatal and Non-fatal)
Timepoint [14] 0 0
Date of MI to 15 months
Secondary outcome [15] 0 0
Incidence: Intracranial Haemorrhage
Timepoint [15] 0 0
Date of MI to 15 months
Secondary outcome [16] 0 0
Time-to-event: Coronary Revascularisation
Timepoint [16] 0 0
Date of MI to 15 months
Secondary outcome [17] 0 0
Incidence: Coronary Revascularisation
Timepoint [17] 0 0
Date of MI to 15 months
Secondary outcome [18] 0 0
Time-to-event: Stent Thrombosis
Timepoint [18] 0 0
Date of MI to 15 months
Secondary outcome [19] 0 0
Incidence: Stent Thrombosis
Timepoint [19] 0 0
Date of MI to 15 months
Secondary outcome [20] 0 0
Time-to-event: Thrombotic Stroke
Timepoint [20] 0 0
Date of MI to 15 months
Secondary outcome [21] 0 0
Incidence: Thrombotic Stroke
Timepoint [21] 0 0
Date of MI to 15 months

Eligibility
Key inclusion criteria
* Aged =18 years
* Clinical diagnosis of Type 1 myocardial infarction within 12 weeks
* In the opinion of the attending clinician requires dual anti-platelet therapy with aspirin and a P2Y12 receptor antagonist
* Resident in the country of recruitment with their unique health identifier
* The attending clinician has equipoise regarding the duration of therapy
* Provision of informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
* Clear indication for specific duration of dual anti-platelet therapy
* Type 2 myocardial infarction
* Contraindication to aspirin or P2Y12 receptor antagonist
* Non-resident in the country of recruitment
* Previous recruitment into the trial
* Inability or unwilling to give informed consent

Study design
Purpose of the study
Treatment
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
Open (masking not 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
26/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/02/2023
Sample size
Target
Accrual to date
Final
5094
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Rotorua
Country [4] 0 0
New Zealand
State/province [4] 0 0
Tauranga
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Aberdeen
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Airdrie
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Ashford
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Ayr
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Blackpool
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Bournemouth
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Bradford
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Bristol
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Carlisle
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Cramlington
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Dorchester
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Dumfries
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Dundee
Country [18] 0 0
United Kingdom
State/province [18] 0 0
East Kilbride
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Edinburgh
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Exeter
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Glasgow
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Greenock
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Hastings
Country [24] 0 0
United Kingdom
State/province [24] 0 0
High Wycombe
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Inverness
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Isleworth
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Kilmarnock
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Kirkcaldy
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Larbert
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Livingston
Country [31] 0 0
United Kingdom
State/province [31] 0 0
London
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Macclesfield
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Melrose
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Middlesbrough
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Oxford
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Paisley
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Perth
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Reading
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Sheffield
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Southampton
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Torquay
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Wigan
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Wishaw
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Yeovil

Funding & Sponsors
Primary sponsor type
Other
Name
University of Edinburgh
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
British Heart Foundation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Newby
Address 0 0
University of Edinburgh
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03252249