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
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is defined as the proportions of patients with new cerebral
micro-infarcts at 6 months relative to baseline measured by MRI.
Secondary outcome
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.
Background summary
Left Ventricular (LV) thrombus formation is witnessed in at least 10% of
patients with ST elevation myocardial infarction (STEMI). It is a feared
complication since it might increase the risk of thrombo-embolic events,
including fatal 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 clopidogrel) to
prevent stent thrombosis. Consequently, STEMI patients with LV thrombus are
currently treated with triple antithrombotic therapy (aspirin, thienopyridine
class antiplatelet agent, 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.
Study 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
Study design
A multicenter, prospective, randomized, non-inferiority trial with blinded
evaluation of endpoints
Intervention
After written informed consent has been obtained, echocardiography and MRI are
performed within 8 weeks 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, e.g. clopidogrel (75 mg/d) 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).
Study burden and risks
high bleeding risk with triple anti-thrombotic therapy versus higher risk
trombolic complications dual anti-platelet therapy
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
1.Suspected LV thrombus on echocardiography or routine MRI ;2.Ongoing treatment with dual antiplatelet therapy (e.g. ASA and clopidogrel) at the time of;randomization
Exclusion criteria
The following exclusion criteria are applied:;1 Younger than 18 ;2 Clinically or hemodynamically unstable;3 Treatment with vitamin K antagonist prior to PCI or other expected indication for vitamin K antagonist treatment (e.g. atrium fibrillation) within the next 6 months;4 Previous stroke or transient ischemic attack ;5 Scheduled for major surgery (including CABG) during the course of the study;6 Active bleeding or high risk for bleeding contraindicating treatment with vitamin K antagonists;7 Contra-indication for vitamin K treatment;8 Chronic treatment with NSAIDs or COX-2 inhibitors for more than 4 days per week anticipated to continue during the study;9 Congenital cardiac disease;10 Presence of supraventricular or ventricular arrhythmias;11 Expected candidate for ICD implantation with the next 6 months;12 Severe renal impairment (estimated glomerular filtration rate (eGFR) <= 30mL/min);13 Known or symptomatic brain disease (e.g. brain tumor);14 Women who are pregnant. ;15 Any contraindication for Contrast-Enhanced Magnetic Resonance Imaging i.e.:;• pacemaker;• cerebrovascular clips ;• known contrast allergy;• claustrophobia;16 Follow-up impossible (no fixed abode, etc)
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 | EUCTR2011-004265-32-NL |
| CCMO | NL37573.018.11 |