The study will assess the hypothesis that the combination warfarin & clopidogrel 75 mg/day is superior to triple therapy (warfarin + clopidogrel 75mg/day + aspirin 80mg/day) with respect to bleeding complications while equally safe with respect…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The combined end point of minor, moderate or major bleeding complications
during the initial hospitalization & one year follow-up.
Secondary outcome
The combined event of death, myocardial infarction, stroke, systemic
embolisation & target vessel revascularisation and the individual components of
the composite primary and secondary endpoints.
Background summary
Chronic oral antithrombotic treatment is necessary in patients with mechanical
heart valves and in the majority of patients with atrial fibrillation. When
these patients have to undergo Percutaneous Coronary Intervention (PCI) with
stenting, there is also an indication for treatment with aspirin and
clopidogrel. However, triple therapy is known to augment the risk for bleeding
complications.
Unfortunately, no prospective data are available to solve this issue.
Nevertheless, it all comes down to finding the ideal therapy in patients with
both atrial fibrillation and percutaneous intervention to prevent thrombotic
complications (e.g. stentthrombosis) without increasing the risk of
bleeding.
This prospective randomised study will assess the hypothesis that in patients
on warfarin therapy and indication for elective percutaneous intervention, the
combination warfarin & clopidogrel 75 mg/day is superior to triple therapy
treatment in reducing the risk of bleeds while equally safe with respect to the
prevention of thrombotic complications
After thorough review of the literature we expect no difference in efficiency
and safety with respect to the prevention of thrombotic complications.
So this is a unique opportunity to prove that dual therapy is superior to
triple therapy in this context.
Study objective
The study will assess the hypothesis that the combination warfarin &
clopidogrel 75 mg/day is superior to triple therapy (warfarin + clopidogrel
75mg/day + aspirin 80mg/day) with respect to bleeding complications while
equally safe with respect to the prevention of thrombotic complications in
patients with both indications for warfarin use and dual antiplatelet
(clopidogrel 75mg/day + aspirin 80mg/day) treatment.
Study design
This is a prospective randomised trial in which at least n=496 patients will be
recruited. We will investigate the effect of the combination
warfarin-clopidogrel versus triple therapy in patients with an indication for
oral anticoagulant therapy use who undergo elective PCI treatment. Patients who
meet the inclusion criteria will be randomised to one of both groups.
follow up is sceduled after 30 days and after 1 year.
Intervention
only patients sceduled for PCI can be included tough this intervention would
also take place without this study. What we want to study is the difference in
outcome after a little change in the antithrombotic treatment
Study burden and risks
For this patient, participating to this study does not imply any additional
risk because we only compare two treatments that are frequently used in daily
practice.
Koekoekslaan 1
3435 CM Nieuwegein
NL
Koekoekslaan 1
3435 CM Nieuwegein
NL
Listed location countries
Age
Inclusion criteria
Patient under warfarin treatment such as patients with atrial fibrillation, mechanical valve... AND with indication for percutaneous coronary intervention
Exclusion criteria
cardiogenic shock, contra-indication for aspirin or clopidogrel, documented peptic ulcer disease within the previous six months, pregnancy and previous intracerebral haemorrhage or significant thrombocytopenia (platelet count < 50x10 9/L).
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-001771-29-NL |
| CCMO | NL20832.100.08 |