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| Name | Class |
|---|---|
| British Heart Foundation | OTHER |
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Despite substantial evidence supporting the use of dual anti-platelet therapy in patients with acute coronary syndrome, there remains major uncertainty regarding the optimal duration of therapy. Recent evidence suggests that shorter durations of dual anti-platelet therapy are superior because the avoidance of atherothrombotic events is counterbalanced by the greater risks of excess major bleeding with apparent increases in all-cause mortality with longer durations. We here propose an international randomised controlled trial of 18,318 patients with type 1 myocardial infarction allocated to differing durations of dual anti-platelet therapy. We will use electronic health record linkage to track duration of therapy and clinical outcomes in a real-world, real-time, efficient and highly cost-effective trial. This has the potential to define treatment duration, settle a major outstanding international controversy, and influence modern cardiology practice across the world.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 months dual anti-platelet therapy | Active Comparator | 3 months dual anti-platelet therapy. |
|
| 12 months dual anti-platelet therapy | Active Comparator | 12 months dual anti-platelet therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3 months dual anti-platelet therapy | Other | Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-event: All-cause Mortality | Restricted Mean Survival Time | Date of index MI to 15 months |
| Incidence: All-cause Mortality | Occurrence of event | Date of index MI to 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-event: Non-cardiovascular Death (Including Fatal Bleeding) and Major Non-fatal Bleeding | Restricted Mean Survival Time | Date of MI to 15 months |
| Incidence: Non-cardiovascular Death (Including Fatal Bleeding) and Major Non-fatal Bleeding |
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-event: Iron Therapy | Restricted Mean Survival Time | Date of MI to 15 months |
| Incidence: Iron Therapy | Occurrence of event | Date of MI to 15 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Newby | University of Edinburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edinburgh Royal Infirmary | Edinburgh | United Kingdom |
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42 participants were excluded from the ITT population following randomisation, those who subsequently became ineligible after a diagnosis other than Type 1 myocardial infarction (MI) and withdrawn from the trial were excluded.
All randomised participants in database.
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| ID | Title | Description |
|---|---|---|
| FG000 | 3 Months Dual Anti-platelet Therapy | 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy. |
| FG001 | 12 Months Dual Anti-platelet Therapy | 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 3 Months Dual Anti-platelet Therapy | 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy. |
| BG001 | 12 Months Dual Anti-platelet Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Missing data |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time-to-event: All-cause Mortality | Restricted Mean Survival Time | Intention to Treat Population. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. | Posted | Mean | Standard Error | days | Date of index MI to 15 months |
|
15 months from date of randomisation.
As the IMPs being used in the study all have marketing authorisations AEs will not be recorded in an AE log, nor reported elsewhere. The study outcomes listed will not be recorded as SAEs and will therefore not be reported to the Sponsor. Once an Investigator becomes aware that a SUSAR has occurred in a study participant, will be reported to the sponsor immediately or within 24 hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 3 Months Dual Anti-platelet Therapy | 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy. |
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The major limitation is that early trial termination meant the target sample size was not achieved, leaving an underpowered trial which was unable to address its primary endpoint. The recruitment suspension due to COVID-19, and the subsequent delays in re-opening of the study sites and lack of staff capacity significantly affected recruitment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor David Newby | University of Edinburgh | 0131 242 6515 | D.E.Newby@ed.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 22, 2022 | Dec 12, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 4, 2025 | Dec 12, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 29, 2020 | Dec 12, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000080903 | Dual Anti-Platelet Therapy |
| ID | Term |
|---|---|
| D004359 | Drug Therapy, Combination |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| 12 months dual anti-platelet therapy | Other | Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy. |
|
Occurrence of event
| Date of MI to 15 months |
| Time-to-event: Non-cardiovascular Death (Including Fatal Bleeding) | Restricted Mean Survival Time | Date of MI to 15 months |
| Incidence: Non-cardiovascular Death (Including Fatal Bleeding) | Occurrence of event | Date of MI to 15 months |
| Time-to-event: Major Fatal and Non-fatal Bleeding | Restricted Mean Survival Time | Date of MI to 15 months |
| Incidence: Major Fatal and Non-fatal Bleeding | Occurrence of event | Date of MI to 15 months |
| Time-to-event: Gastrointestinal Bleeding | Restricted Mean Survival Time | Date of MI to 15 months |
| Incidence: Gastrointestinal Bleeding | Occurrence of event | Date of MI to 15 months |
| Time-to-event: Cardiovascular Death and Non-fatal Myocardial Infarction | Restricted Mean Survival Time | Date of MI to 15 months |
| Incidence: Cardiovascular Death and Non-fatal Myocardial Infarction | Occurrence of event | Date of MI to 15 months |
| Time-to-event: Cardiovascular Mortality (Cardiac and Non-cardiac) | Restricted Mean Survival Time | Date of MI to 15 months |
| Incidence: Cardiovascular Mortality (Cardiac and Non-cardiac) | Occurrence of event | Date of MI to 15 months |
| Time-to-event: Myocardial Infarction (Fatal and Non-fatal) | Restricted Mean Survival Time | Date of MI to 15 months |
| Incidence: Myocardial Infarction (Fatal and Non-fatal) | Occurrence of event | Date of MI to 15 months |
| Incidence: Intracranial Haemorrhage | Occurrence of event | Date of MI to 15 months |
| Time-to-event: Coronary Revascularisation | Restricted Mean Survival Time | Date of MI to 15 months |
| Incidence: Coronary Revascularisation | Occurrence of event | Date of MI to 15 months |
| Time-to-event: Stent Thrombosis | Restricted Mean Survival Time | Date of MI to 15 months |
| Incidence: Stent Thrombosis | Occurrence of event | Date of MI to 15 months |
| Time-to-event: Thrombotic Stroke | Restricted Mean Survival Time | Date of MI to 15 months |
| Incidence: Thrombotic Stroke | Occurrence of event | Date of MI to 15 months |
| Time-to-event: Blood Transfusion | Restricted Mean Survival Time | Date of MI to 15 months |
| Incidence: Blood Transfusion | Occurrence of event | Date of MI to 15 months |
12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy. |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Social Deprivation | Each health authority used its own definition: Scotland used SIMD (Scottish Index of Multiple Deprivation), England used EIMD (English Index of Multiple Deprivation) and New Zealand used NZDep (New Zealand Index of Deprivation). | Count of Participants | Participants |
|
| Clinical Management at Randomisation | Count of Participants | Participants |
|
|
|
| Primary | Incidence: All-cause Mortality | Occurrence of event | Intention to Treat Population. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. | Posted | Count of Participants | Participants | Date of index MI to 15 months |
|
|
|
|
| Secondary | Time-to-event: Non-cardiovascular Death (Including Fatal Bleeding) and Major Non-fatal Bleeding | Restricted Mean Survival Time | The intention to treat (ITT) principle. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. | Posted | Mean | Standard Error | days | Date of MI to 15 months |
|
|
|
| Secondary | Incidence: Non-cardiovascular Death (Including Fatal Bleeding) and Major Non-fatal Bleeding | Occurrence of event | The intention to treat (ITT) principle. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. | Posted | Number | participants | Date of MI to 15 months |
|
|
|
|
| Secondary | Time-to-event: Non-cardiovascular Death (Including Fatal Bleeding) | Restricted Mean Survival Time | Intention to Treat Population. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. | Posted | Mean | Standard Error | days | Date of MI to 15 months |
|
|
|
| Secondary | Incidence: Non-cardiovascular Death (Including Fatal Bleeding) | Occurrence of event | The intention to treat (ITT) principle. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. | Posted | Number | participants | Date of MI to 15 months |
|
|
|
|
| Secondary | Time-to-event: Major Fatal and Non-fatal Bleeding | Restricted Mean Survival Time | Intention to Treat Population. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. | Posted | Mean | Standard Error | days | Date of MI to 15 months |
|
|
|
| Secondary | Incidence: Major Fatal and Non-fatal Bleeding | Occurrence of event | The intention to treat (ITT) principle. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. | Posted | Number | participants | Date of MI to 15 months |
|
|
|
|
| Secondary | Time-to-event: Gastrointestinal Bleeding | Restricted Mean Survival Time | Intention to Treat Population. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. | Posted | Mean | Standard Error | days | Date of MI to 15 months |
|
|
|
| Secondary | Incidence: Gastrointestinal Bleeding | Occurrence of event | The intention to treat (ITT) principle. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. | Posted | Count of Participants | Participants | Date of MI to 15 months |
|
|
|
|
| Secondary | Time-to-event: Cardiovascular Death and Non-fatal Myocardial Infarction | Restricted Mean Survival Time | Intention to Treat Population. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. | Posted | Mean | Standard Error | days | Date of MI to 15 months |
|
|
|
| Secondary | Incidence: Cardiovascular Death and Non-fatal Myocardial Infarction | Occurrence of event | The intention to treat (ITT) principle. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. | Posted | Count of Participants | Participants | Date of MI to 15 months |
|
|
|
|
| Secondary | Time-to-event: Cardiovascular Mortality (Cardiac and Non-cardiac) | Restricted Mean Survival Time | Intention to Treat Population. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. | Posted | Mean | Standard Error | days | Date of MI to 15 months |
|
|
|
| Secondary | Incidence: Cardiovascular Mortality (Cardiac and Non-cardiac) | Occurrence of event | The intention to treat (ITT) principle. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. | Posted | Count of Participants | Participants | Date of MI to 15 months |
|
|
|
|
| Secondary | Time-to-event: Myocardial Infarction (Fatal and Non-fatal) | Restricted Mean Survival Time | Intention to Treat Population. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. | Posted | Mean | Standard Error | days | Date of MI to 15 months |
|
|
|
| Secondary | Incidence: Myocardial Infarction (Fatal and Non-fatal) | Occurrence of event | The intention to treat (ITT) principle. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. | Posted | Count of Participants | Participants | Date of MI to 15 months |
|
|
|
|
| Secondary | Incidence: Intracranial Haemorrhage | Occurrence of event | The intention to treat (ITT) principle. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. | Posted | Count of Participants | Participants | Date of MI to 15 months |
|
|
|
| Secondary | Time-to-event: Coronary Revascularisation | Restricted Mean Survival Time | Intention to Treat Population. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. | Posted | Mean | Standard Error | days | Date of MI to 15 months |
|
|
|
| Secondary | Incidence: Coronary Revascularisation | Occurrence of event | The intention to treat (ITT) principle. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. | Posted | Count of Participants | Participants | Date of MI to 15 months |
|
|
|
|
| Secondary | Time-to-event: Stent Thrombosis | Restricted Mean Survival Time | Intention to Treat Population. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. | Posted | Mean | Standard Error | days | Date of MI to 15 months |
|
|
|
| Secondary | Incidence: Stent Thrombosis | Occurrence of event | The intention to treat (ITT) principle. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. | Posted | Count of Participants | Participants | Date of MI to 15 months |
|
|
|
|
| Secondary | Time-to-event: Thrombotic Stroke | Restricted Mean Survival Time | Intention to Treat Population. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. | Posted | Mean | Standard Error | days | Date of MI to 15 months |
|
|
|
| Secondary | Incidence: Thrombotic Stroke | Occurrence of event | The intention to treat (ITT) principle. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. | Posted | Count of Participants | Participants | Date of MI to 15 months |
|
|
|
|
| Other Pre-specified | Time-to-event: Iron Therapy | Restricted Mean Survival Time | Intention to Treat Population. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. As specified in the protocol, other endpoints will be collected where possible and therefore there is missing data. | Posted | Mean | Standard Error | days | Date of MI to 15 months |
|
|
|
| Other Pre-specified | Incidence: Iron Therapy | Occurrence of event | The intention to treat (ITT) principle. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. As specified in the protocol, other endpoints will be collected where possible and therefore there is missing data. | Posted | Count of Participants | Participants | Date of MI to 15 months |
|
|
|
|
| Other Pre-specified | Time-to-event: Blood Transfusion | Restricted Mean Survival Time | Intention to Treat Population. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. As specified in the protocol, other endpoints will be collected where possible and therefore there is missing data. | Posted | Mean | Standard Error | days | Date of MI to 15 months |
|
|
|
| Other Pre-specified | Incidence: Blood Transfusion | Occurrence of event | The intention to treat (ITT) principle. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. As specified in the protocol, other endpoints will be collected where possible and therefore there is missing data. | Posted | Count of Participants | Participants | Date of MI to 15 months |
|
|
|
|
| 68 |
| 2,526 |
| 0 |
| 2,526 |
| 0 |
| 2,526 |
| EG001 | 12 Months Dual Anti-platelet Therapy | 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy. | 87 | 2,526 | 0 | 2,526 | 0 | 2,526 |
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| D003327 |
| Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| Not available |
|
| Asian |
|
| Black |
|
| Other |
|
| Not stated or not known |
|
| Missing |
|
| Data not collected for Scotland or New Zealand |
|
| Quintile 3 |
|
| Quintile 4 |
|
| Quintile 5 (least deprived) |
|
| Not recorded |
|
| Missing |
|
| Bare metal stent |
|
| Medical management |
|
| Conservative |
|
| ICA planned |
|