Acute coronary syndrome MedDRA version: 18.1 Level: LLT Classification code 10064348 Term: Non STEMI System Organ Class: 100000004849 MedDRA version: 18.1 Level: LLT Classification code 10064346 Term: STEMI System Organ Class: 100000004849 MedDRA version: 18.1 Level: LLT Classification code 10002385 Term: Angina pectoris unstable System Organ Class: 100000004849
Conditions
Interventions
Trade Name: Aspirin
Product Name: Aspirin
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Plavix
Pharmaceutical For
Sponsors
Diagram B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient must be =18 years of age 2. The patient has been diagnosed with STEMI, NSTEMI or UA 3. The Patient is willing to comply with specified follow-up evaluations 4. The Patient has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics Committee (MEC), Institutional Review Board (IRB), or Human Research Ethics Committee (HREC) 5. Successful COMBO stent implantation (TIMI 3 flow with residual stenosis =65 years) yes F.1.3.1 Number of subjects for this age range 750
Exclusion criteria
Exclusion criteria: 1. Patients presenting with cardiogenic shock 2. Patients with recent major bleeding complications or contraindication to DAPT, such as: a) Hypersensitivity to Aspirin, Clopidogrel, Prasugrel or Ticagrelor b) Need for oral anticoagulation c) History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia) or refusal of blood transfusions d) History of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke e) Stroke or transient ischemic attack within the past 6 months or any permanent residual neurologic defect f) Gastrointestinal or genitourinary bleeding within the last 2 months or major surgery within 6 weeks g) Recent history (<3 months prior to randomization) or known current platelet count <100 000 cells/mm3 or hemoglobin <10 g/dL h) An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 12 months post enrollment 3. Planned need for concomitant cardiac surgery (e.g., valve surgery or resection of aortic or left ventricular aneurysm etc.) 4. Planned intervention of another lesion (target vessel or non-target vessel) after index hospital discharge 5. Any revascularization performed within index hospitalization with other stents than COMBO 6. Potential for non-compliance towards the requirements in the trial protocol (especially the medical treatment) or follow-up visits 7. Patients requiring permanent DAPT due to comorbidities 8. Patient has received any organ transplant or is on a waiting list for any organ transplant 9. Life expectancy of less than 2 years 10. Pregnancy or intention to become pregnant during the course of the trial 11. Any significant medical or mental condition, which in the Investigator’s opinion may interfere with the patient’s optimal participation in the study 12. Currently participating in another investigational drug or device study 13. Patients who have been treated with another DES within 9 months prior to the index procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate safety of 90-days versus standard 360-days of DAPT;Secondary Objective: Not applicable;Primary end point(s): Composite of all cause mortality, myocardial infarction (MI), stent thrombosis (ST), stroke, target vessel revascularisation (TVR), bleeding (BARC II, III, V) at 360 days;Timepoint(s) of evaluation of this end point: 360 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Bleeding (BARC II, III, V) at 360 days - All cause mortality, MI, ST, stroke, TVR, bleeding (BARC II, III, V) at 720 days - All cause mortality, MI, ST, stroke and TVR at 360 and 720 days - Mortality at 360 and 720 days - Cardiac Mortality at 360 and 720 days - Any MI at 360 and 720 days - ST at 360 and 720 days - Repeat revascularization at 360 and 720 days - Time to event as defined by the occurrence of one of the following: all cause mortality, MI, ST, stroke, TVR or bleeding (BARC II, III, V) within 360 and 720 days - Prespecified landmark analysis of Primary Endpoint (without TVR) from 90 and 360 days;Timepoint(s) of evaluation of this end point: - 360 days - 720 days | — |
Countries
Belgium, Germany, Hong Kong, Hungary, Indonesia, Italy, Malaysia, Netherlands, Poland, Singapore, Thailand
Contacts
Public ContactJ. Klijn
Diagram B.V.
Outcome results
None listed