Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT01556659 |
| Other study ID # |
2011-004265-32 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2012 |
| Est. completion date |
June 2022 |
Study information
| Verified date |
April 2024 |
| Source |
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Left Ventricular (LV) thrombus formation is witnessed in at least 10% of patients with ST
segment elevation myocardial infarction (STEMI). It is a feared complication since it might
increase the risk of thrombo-embolic events, including stroke. Guidelines recommend vitamin K
antagonist treatment in these patients. However patients with STEMI nowadays undergo primary
percutaneous coronary intervention (PCI) with coronary stent placement and consequently
require dual anti-platelet therapy (ascal and P2Y12 inhibitors) to prevent stent thrombosis.
Consequently, STEMI patients with LV thrombus are currently treated with triple
antithrombotic therapy (aspirin, P2Y12 inhibitors, e.g. clopidogrel (75 mg/d) and vitamin K
antagonist). Patients treated with triple antithrombotic therapy are subject to a strongly
increased bleeding risk with a yearly incidence of 3.7% for dual anti-platelet therapy as
compared to 12% for triple antithrombotic therapy. About 10% of these bleedings are cerebral.
The mortality of such haemorrhagic strokes is 25%. A recent retrospective analysis did not
show any beneficial effects of addition of vitamin K antagonist to dual anti-platelet therapy
to prevent stroke. If vitamin K antagonist-therapy could be omitted, morbidity and mortality
due to post-PCI bleedings will decrease. Therefore, a randomized trial is warranted to
address this issue.
Design: A multicenter, prospective, randomized, two non-inferiority trial. The objective of
the study is to determine in a randomized fashion the risks and benefits of the addition of
vitamin K antagonists to dual anti-platelet therapy or dual anti-platelet therapy in patients
with PCI-treated STEMI and LV thrombus formation on baseline echocardiography or baseline
Magnetic Resonance Imaging (MRI).
Description:
Design: A multicenter, prospective, randomized, non-inferiority trial with blinded evaluation
of endpoints
Objective: The objective of this study is to determine in a randomized fashion the risks as
well as the benefits of the addition of vitamin K antagonists to dual anti-platelet therapy
in patients with PCI-treated STEMI and LV thrombus formation
Patients: Patients with acute myocardial infarction treated with primary PCI and LV thrombus
on baseline echocardiography or baseline Magnetic Resonance Imaging. (MRI)
Methods: After written informed consent has been obtained, echocardiography and MRI are
performed between 7-12 days after PCI. When LV thrombus is present on baseline MRI, patients
are randomized to
1. Triple antithrombotic therapy (aspirin (100 mg/d), thienopyridine class antiplatelet
agent,) and vitamin K antagonist (goal INR is 2.0 to 3.0))
2. Dual anti-platelet therapy (aspirin (100mg/d) and thienopyridine class antiplatelet
agent, e.g. clopidogrel (75 mg/d).
Primary Endpoint: Primary outcome is defined as the proportions of patients with new cerebral
micro-infarcts at 6 months relative to baseline measured by MRI.
Secondary Endpoints: The secondary endpoints as assessed at 6 and 12 months are:
- the composite of vascular death, recurrent myocardial infarction, stroke or systemic
embolism
- presence of new cerebral mirco-bleeds
- the occurrence of major and minor bleeding
- neurological status and quality of life.
