Randomized Evaluation of short-term DUal anti platelet therapy in patients with acute coronary syndrome treated with the COMBO dual-therapy stEnt

Conditions: Acute coronary syndrome
MedDRA version: 17.1Level: LLTClassification code 10064348Term: Non STEMISystem Organ Class: 100000004849
MedDRA version: 17.1Level: LLTClassification code 10064346Term: STEMISystem Organ Class: 100000004849
MedDRA version: 17.1Level: LLTClassification code 10002385Term: Angina pectoris unstableSystem Organ Class: 100000004849
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2013-005571-40-IT

Lead Sponsor: Diagram B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 1500

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 < 20% based visual estimation), with no clinical adverse event during hospitalization (Death, stent thrombosis (ST), stroke, target vessel revascularisation (TVR), bleeding (BARC II, III, V))
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 750
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 750

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 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate safety of 3-months versus standard 12-months of DAPT;Secondary Objective: Not applicable;Primary end point(s): Composite of all cause mortality, myocardial infarction (MI), stent thrombosis (ST), stroke, bleeding (BARC II, III, V) at 12 months;Timepoint(s) of evaluation of this end point: 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Bleeding (BARC II, III, V) at 12 months<br>- All cause mortality, MI, ST, stroke, bleeding (BARC II, III, V) at 24 months <br>- All cause mortality, MI, ST, stroke at 12 and 24 months <br>- Cardiac Mortality at 12 and 24 months <br>- Any MI at 12 and 24 months <br>- ST at 12 and 24 months <br>- Repeat revascularization at 12 and 24 months <br>- Time to event analysis primary endpoint;Timepoint(s) of evaluation of this end point: - time to event primary endpoint<br>- 12 months<br>- 24 months

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