Myocardial Infarction Clinical Trial
Official title:
Comparison of Ticagrelor and Clopidogrel on Reperfusion in Patients With AMI Undergoing PPCI Evaluated by SPECT
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.
Status | Not yet recruiting |
Enrollment | 600 |
Est. completion date | December 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | The First Hospital of China Medical University | Shenyang | Liaoning |
Lead Sponsor | Collaborator |
---|---|
First Hospital of China Medical University | AstraZeneca |
China,
Gurbel PA, Bliden KP, Butler K, Tantry US, Gesheff T, Wei C, Teng R, Antonino MJ, Patil SB, Karunakaran A, Kereiakes DJ, Parris C, Purdy D, Wilson V, Ledley GS, Storey RF. Randomized double-blind assessment of the ONSET and OFFSET of the antiplatelet effects of ticagrelor versus clopidogrel in patients with stable coronary artery disease: the ONSET/OFFSET study. Circulation. 2009 Dec 22;120(25):2577-85. doi: 10.1161/CIRCULATIONAHA.109.912550. Epub 2009 Nov 18. — View Citation
Mahaffey KW, Puma JA, Barbagelata NA, DiCarli MF, Leesar MA, Browne KF, Eisenberg PR, Bolli R, Casas AC, Molina-Viamonte V, Orlandi C, Blevins R, Gibbons RJ, Califf RM, Granger CB. Adenosine as an adjunct to thrombolytic therapy for acute myocardial infarction: results of a multicenter, randomized, placebo-controlled trial: the Acute Myocardial Infarction STudy of ADenosine (AMISTAD) trial. J Am Coll Cardiol. 1999 Nov 15;34(6):1711-20. — View Citation
Ross AM, Gibbons RJ, Stone GW, Kloner RA, Alexander RW; AMISTAD-II Investigators. A randomized, double-blinded, placebo-controlled multicenter trial of adenosine as an adjunct to reperfusion in the treatment of acute myocardial infarction (AMISTAD-II). J Am Coll Cardiol. 2005 Jun 7;45(11):1775-80. — View Citation
Steg PG, James S, Harrington RA, Ardissino D, Becker RC, Cannon CP, Emanuelsson H, Finkelstein A, Husted S, Katus H, Kilhamn J, Olofsson S, Storey RF, Weaver WD, Wallentin L; PLATO Study Group. Ticagrelor versus clopidogrel in patients with ST-elevation acute coronary syndromes intended for reperfusion with primary percutaneous coronary intervention: A Platelet Inhibition and Patient Outcomes (PLATO) trial subgroup analysis. Circulation. 2010 Nov 23;122(21):2131-41. doi: 10.1161/CIRCULATIONAHA.109.927582. Epub 2010 Nov 8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | severe brachycardia arrhythmia | 1 month | Yes | |
Primary | myocardial infarcted size | To evaluate the infarcted size on Day 7 after PPCI by SPECT. | 1 week | No |
Secondary | elevated ST segment resolution | To observe the elevated ST segment resolution at 1 h and 24 h after PPCI; | 1 hour and 24 hours | No |
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