Overview

Ticagrelor Versus Clopidogrel in Left Ventricular Remodeling After ST-segment Elevation Myocardial Infarction

Status:
Unknown status
Trial end date:
2017-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the study is to evaluate the novel role of ticagrelor to improve long-term LV remodeling following ST-segment elevation myocardial infarction.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gyeongsang National University Hospital
Collaborators:
Chinese PLA General Hospital
Chonnam National University Hospital
Chungbuk National University Hospital
Chungnam National University Hospital
Kyunghee University Medical Center
Kyungpook National University
Kyungpook National University Hospital
National University Heart Centre, Singapore
Pusan National University Yangsan Hospital
Samsung Changwon Hospital
Seoul National University Bundang Hospital
Ulsan University Hospital
Treatments:
Clopidogrel
Ticagrelor
Ticlopidine
Criteria
Inclusion Criteria:

- 18 years and older.

- First-time onset STEMI patients uneventfully treated with primary PCI within 12 hours
of onset of symptom.

- Infarct-related artery with TIMI 0, 1, or 2 grade flow at the time of initial
diagnostic angiography (before wire passage).

- proximal or mid-portion lesion of epicardial coronary artery.

Exclusion Criteria:

- Previous history of myocardial infarction.

- Left bundle branch block on ECG at the time of screening.

- Cardiogenic shock at the time of randomization.

- Refractory ventricular arrhythmias or atrial fibrillation.

- New York Heart Association class IV congestive heart failure.

- Severe or malignant hypertension (SBP> 180 and/or DBP> 120 mmHg).

- Fibrinolytic therapy.

- History of hemorrhagic stroke.

- Intracranial neoplasm, arteriovenous malformation, or aneurysm.

- Ischemic stroke within 3 months prior to screening.

- Platelet count < 100,000/mm3 or hemoglobin < 10 g/dL.

- A need for oral anticoagulation therapy that cannot be safely discontinued for the
duration of the study.

- Women who are known to be pregnant, have given birth within the past 90 days, or are
breast-feeding.

- Unable to cooperate with protocol requirements and follow-up procedures.

- A history of P2Y12 receptor inhibitor pretreatment (at least prior 1 month).

- An increased risk of bradycardia.

- Concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer.