To evaluate safety of 3-months versus standard 12-months of DAPT
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
All cause mortality, MI, ST, stroke, TVR, bleeding (BARC II, III, V) at 12
months
Secondary outcome
Bleeding (BARC II, III, V) at 12 months
All cause mortality, MI, ST, stroke, TVR, bleeding (BARC II, III, V) at 24
months
All cause mortality, MI, ST, stroke and TVR at 12 and 24 months
Mortality at 12 and 24 months
Cardiac Mortality at 12 and 24 months
Any MI at 12 and 24 months
ST at 12 and 24 months
Repeat revascularization at 12 and 24 months
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 12 and 24
months
Prespecified landmark analysis of Primary Endpoint (without TVR) from 3 to 12
months
Background summary
The optimal duration of dual antiplatelet therapy in ACS patients treated with
DES is still under debate. This is especially true for STEMI patients in the
era of new anticoagulants and antiplatelet agents. Yet, the potential benefits
of longterm dual antiplatelet therapy in avoiding thrombotic complications may
be clearly counterbalanced by a higher risk of major bleeding complications. In
particular, the COMBO dual therapy stent, being associated with early
re-endothelization, may allow for a reduction of the duration of DAPT without
increasing the thrombotic risk, while reducing the risk of severe bleeding
complications.
Study objective
To evaluate safety of 3-months versus standard 12-months of DAPT
Study design
Prospective, multicenter, randomized investigator-initiated study designed to
enroll 1500 patients with ACS receiving a COMBO stent. Patients will be
randomized before discharge into a 1:1 fashion to either 3 or 12 months DAPT.
Follow-up is scheduled at 3, 6, 12, and 24 months.
Intervention
intervention: 3 months DAPT
control: 12 months DAPT
Study burden and risks
Antiplatelet therapy helps to prevent blood vessels to occlude/obstruct. A side
effect of antiplatelet therapy is that the risk of bleeding complications
rises.
The most apparent side effects of Aspirin administration are the following,
although they occur infrequently:
- ulcers of the stomach and duodenum (first part of the small intestine)
- abdominal pain
- nausea
- gastritis (inflammation of the stomach)
- even serious gastrointestinal bleeding from ulcers
- occasionally, aspirin may be toxic to the liver
The most apparent side effects of a P2Y12 receptor inhibitor (Clopidogrel,
Prasugrel or Ticagrelor) are the following:
- bleeding
- shortness of breath
- ventricular pause
- increase of serum uric acid and serum creatinine
Dokter Stolteweg 96
Zwolle 8025AZ
NL
Dokter Stolteweg 96
Zwolle 8025AZ
NL
Listed location countries
Age
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))
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-005571-40-NL |
| ClinicalTrials.gov | NCT02118870 |
| CCMO | NL47464.075.13 |
| OMON | NL-OMON20593 |