Ticagrelor and Clopidogrel on Reperfusion in Patients With AMI
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|ClinicalTrials.gov Identifier: NCT02233790|
Recruitment Status : Unknown
Verified September 2014 by Yingxian Sun, First Hospital of China Medical University.
Recruitment status was: Not yet recruiting
First Posted : September 8, 2014
Last Update Posted : September 8, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction No-Reflow Phenomenon||Drug: Ticagrelor Drug: Clopidogrel||Phase 4|
The patients with acute myocardial infarction (AMI) present high mortality and morbidity rate, and also have malignant prognosis even if they could survive. The mortality and prognosis has been improved markedly because of the treatment with primary percutaneous coronary intervention (PPCI). However, the issue of no-reflow after revascularization has not been solved yet. The mechanisms of no-reflow in human being were regarded mainly as micro-embolism in coronary micro-circulation with thrombus or debris from atherosclerotic plaque, coronary micro-vasculature spasm and other conditions.
Therefore, an agent with potent antithrombotic and micro-vasculature dilation function would be more effective on prevention of no-reflow after coronary revascularization. Ticagrelor was demonstrated to be a potent platelet inhibitor and a potent micro-vessel dilator which can influence metabolism of adenosine.
Ticagrelor can inhibit adenosine uptake in vitro and subsequently augments cardiac blood flow in a canine model of reactive hypoxia- or adenosine-induced blood flow increases. In a dog coronary thrombosis model, ticagrelor blocks ADP-induced platelet activation and aggregation; prevents platelet-mediated thrombosis; prolongs reperfusion time and reduces re-occlusion and cyclic flow variation; and significantly decreases infarct size and rapidly restores myocardial tissue perfusion. These findings suggest that ticagrelor may have additional benefits in patients with acute coronary syndrome beyond inhibition of platelet aggregation, which is advantageous to the dilation of microcirculation and improvement of myocardial perfusion. AMISTAD study shows that: adenosine reperfusion therapy can reduce 33% of the infarction area assessed by single-photon emission computed tomography (SPECT) detection. AMISTAD- 2 study showed that: adenosine early reperfusion therapy can reduce the composite end point of death and heart failure events. Additionally, ticagrelor is a non-precursor agent, playing a role directly on platelet inhibition.
Myocardial perfusion imaging with SPECT is among the most widely used and well-established noninvasive tools for the diagnosis of ischemic coronary disease. It has been shown to have a high sensitivity and specificity in identifying patients with coronary artery disease and to be accurate in identifying areas of prior myocardial infarction.
Given the evidence (from PLATO trial) of greater IPA with ticagrelor than clopidogrel, similar risk of major bleeding and probable effect of micro-vasculature dilation due to adenosine, ticagrelor will improve the reperfusion and decrease the infarct size significantly.
This study is to test the effectiveness of ticagrelor on improving reperfusion and minimizing the myocardial infarct size after PPCI in patients with AMI. Also, it is to evaluate the safety of ticagrelor in patients with AMI.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Ticagrelor and Clopidogrel on Reperfusion in Patients With AMI Undergoing PPCI Evaluated by SPECT|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||December 2016|
a loading dose of 180mg pre-PCI, and then 90 mg twice daily for 1 Month within the study. Thereafter, the patients will take clopidogrel if Ticagrelor is not available on the market.
Other Name: Brilinta
|Active Comparator: Clopidogrel||
Clopidogrel 75 mg once daily after a loading dose of 300 mg pre-PCI.
Other Name: Plavix
- myocardial infarcted size [ Time Frame: 1 week ]To evaluate the infarcted size on Day 7 after PPCI by SPECT.
- elevated ST segment resolution [ Time Frame: 1 hour and 24 hours ]To observe the elevated ST segment resolution at 1 h and 24 h after PPCI;
- severe brachycardia arrhythmia [ Time Frame: 1 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02233790
|Contact: Yingxian Sun, Dr.||firstname.lastname@example.org|
|Contact: Wen Tian, Dr.||email@example.com|
|The First Hospital of China Medical University|
|Shenyang, Liaoning, China, 110001|
|Contact: Jianhua Tong, Master 0086-24-83282837 firstname.lastname@example.org|
|Sub-Investigator: Wen Tian, Dr.|
|Principal Investigator:||Yingxian Sun, Dr.||First Hospital of China Medical University|