The safety of ticagrelor monotherapy after primary percutaneous coronary intervention for ST-elevation myocardial infarction and the effect on intramyocardial haemorrhage

Recruiting

Conditions: ST-elevation myocardial infarction
heart attack
10011082

Registration Number: NL-OMON56396

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

Patients aged 18 years or older are eligible for inclusion if all of the
following criteria are met:
- Clinical and electrocardiographical diagnosis of ST-elevation myocardial
infarction (STEMI)
- Successful percutaneous coronary intervention (PCI) of the infarct-related
vessel with a modern
drug eluting stent (DES)

Exclusion Criteria

- Known allergy or contraindication for aspirin, ticagrelor or prasugrel.
- Previous PCI or MI less than 12 months ago
- Previous cardiac surgery
- Participation in another clinical study with an investigational product
- Pregnancy and breast feeding
- Concurrent use of oral anticoagulants (OAC)
- The periprocedural use of GPIIb/IIIa inhibitors
- Planned surgical intervention within 12 months of PCI
- Creatinine clearance <30 mL/min or dialysis
- PCI of stent thrombosis
- Suboptimal stent result as judged by the interventional cardiologist.
- Contra-indications for MRI or unable to undergo MRI (only applicable for the
CMR subgroup population).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints:<br /><br>Composite of major adverse cardiac and cerebral events (MACCE), consisting of:<br /><br>- Myocardial infarction<br /><br>- Stent thrombosis<br /><br>- Ischemic stroke<br /><br>- Cardiovascular mortality/All-cause mortality</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>• IMH and infarct size measured by CMR<br /><br>• Bleeding complications BARC >= 2<br /><br>• Platelet reactivity in ticagrelor monotherapy and tcagrelor + ASA<br /><br>• All-cause mortality</p><br>