Status:
UNKNOWN
Efficacy of Ticagrelor vs Clopidogrel in High-risk NSTE-ACS Patients Undergoing Early PCI
Lead Sponsor:
RenJi Hospital
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The goal of acute coronary syndrome (ACS) therapy is to successfully restore both epicardial blood flow and myocardial perfusion. Percutaneous coronary intervention (PCI) has been documented as being ...
Detailed Description
The goal of acute coronary syndrome (ACS) therapy is to successfully restore both epicardial blood flow and myocardial perfusion. Percutaneous coronary intervention (PCI) has been documented as being ...
Eligibility Criteria
Inclusion
- For inclusion in the study subjects should fulfill the following criteria:
- Provision of informed consent prior to any study specific procedures;
- Men or women \> 18 years of age, with documented evidence of non-ST segment elevation Acute Coronary Syndrome(ACS) in the 24 hours before randomisation;
- Hospitalized for high-risk non-ST segment elevation Acute Coronary Syndrome(ACS)(GRACE risk score\>140) with indication for early percutaneous coronary intervention (PCI) according to 2012 Chinese non-S T segment elevation Acute Coronary Syndrome(ACS) guideline recommendation.
Exclusion
- Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- Evidence of cardiac rupture;
- History of major hemorrhage (intracranial, gastrointestinal, etc.);
- Active pathological bleeding;
- Acute or chronic hematologic disorder including a Hemoglobin less than 10 g/L or a platelet count less than 10×109/L before procedure;
- Contraindication against the use of clopidogrel and ticagrelor;
- 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.
- Severe complication 7.1 Other diseases with life expectancy ≤12 months; 7.2 Any history of Severe renal or hepatic dysfunction(hepatic failure, cirrhosis, portal hypertension and active hepatitis); Neutropenia, thrombocytopenia ; Known acute pancreatitis; 7.3 Arterial aneurysm, arterial/venous malformation and aorta dissection;
- Complex heart condition 8.1 PCI within previous 1 month or Previous coronary-artery bypass surgery(CABG); 8.2 History of myocardial infarction; 8.3 Previously known multivessel coronary artery disease not suitable for percutaneous coronary intervention (PCI);
- Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 30 days;
- Treatment with anticoagulants;
- Pregnancy or lactating;
- Body weight \<40kg or \>125kg;
- Known hypersensitivity to any drug that may appear in the study;
- Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk;
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2016
Estimated Enrollment :
444 Patients enrolled
Trial Details
Trial ID
NCT02201667
Start Date
August 1 2014
End Date
October 1 2016
Last Update
August 4 2014
Active Locations (1)
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1
Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 200127