Overview

Ticagrelor and Clopidogrel on Reperfusion in Patients With AMI

Status:
Unknown status
Trial end date:
2016-12-01
Target enrollment:
0
Participant gender:
All
Summary
The patients with acute myocardial infarction (AMI) present high mortality and morbidity rate,even treated with stenting in the blocked heart vessels. The appearance of no-reflow is common after re-opening of the blocked vessel. The no-reflow were commonly attributed to tiny blockage in coronary micro-vasculature by thrombus and spasm of the micro-vessel during stenting. An agent with more effective anti-clotting and micro-vessel dilation would be helpful to solve the issue of no-reflow. Ticagrelor was demonstrated to be a potent platelet inhibitor and a potent micro-vessel dilator which can influence metabolism of adenosine, a endogenous potent small vessel dilator. This study is to test the effectiveness of ticagrelor on improving reperfusion and minimizing the myocardial infarct size after PPCI in patients with AMI.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
First Hospital of China Medical University
Collaborator:
AstraZeneca
Treatments:
Clopidogrel
Ticagrelor
Ticlopidine
Criteria
Inclusion Criteria:

- Provision of informed consent prior to any study specific procedures

- Patients with acute ST-segment elevation myocardial infarction, an onset of symptoms
presented within 12 hours. Two criteria have to be met: persistent ST-segment
elevation of at least 0.1 mV in at least two contiguous leads or a new left
bundle-branch block, and the intention to perform primary PCI

- Patients must agree to undergo all protocol-required follow-up examinations and not to
participate any other clinical trials within the duration of this study

Exclusion Criteria:

- Any contraindication against the use of clopidogrel or ticagrelor

- Fibrinolytic therapy within 24 hours before randomization

- Stroke within the previous 6 months or intracranial hemorrhage at any time before
randomization

- Any other concomitant severe organic or systemic disorder, such as severe liver
(ALT>3×ULN )or renal disease(creatinin>5.0mg/dl or 442μmol/L), etc.

- A need for oral anticoagulation therapy

- An increased risk of bradycardia or atrial-ventricle block

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

- Pregnant women or breast-feeding, or planning to become pregnant while enrolled in
this study

- Subject has any condition for which, in the opinion of the investigator, participation
would not be in the best interest of the subject (eg, compromise the well-being) or
that could prevent, limit, or confound the protocol-specified assessments