Safety and Efficacy of Low-Dose Ticagrelor in Chinese Patients With NSTE-ACS

Status unconfirmed · Phase 3

Conditions studied: Non ST Segment Elevation Acute Coronary Syndrome

In brief

Ticagrelor is an oral, reversibly-binding, direct-acting P2Y12 receptor antagonist used clinically for the prevention of atherothrombotic events in patients with acute coronary syndromes (ACS). Guideline recommendations on the use of dual antiplatelet therapy (DAPT) have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for patients who have an ACS with or without ST-segment elevation. These recommendations are primarily based on large, randomized, Phase III clinical trials. However, few East Asian patients (or those of East Asian descent) have been included in these trials to assess the use of these drugs. In addition, a growing body of data supported that East Asian might have different adverse event profiles (thrombophilia and bleeding) and "therapeutic window" compared with white subjects. Furthermore, "East Asian paradox" phenomenon has been described that East Asian patients have a higher prevalence of platelet reactivity during DAPT, but an ischaemic event rate following PCI or ACS is similar or even lower than white patients. Therefore, the antiplatelet treatment strategy that is most appropriate for East Asian patients is increasingly urgent. Therefore, we performed the current study to observe the different effects of low-dose ticagrelor (45 mg twice daily), conventional-dose ticagrelor (90 mg twice daily) and clopidogrel (75mg once daily) on high platelet reactivity (HPR) and IPA, and investigated the safety and efficacy of low-dose ticagrelor further in Chinese patients with non-ST-elevation ACS (NSTE-ACS).

Key facts

Study ID

NCT02415803

Run by

First Affiliated Hospital of Harbin Medical University

People needed

75

Starts

2014-12-01

Last updated by the study team

2015-04-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• hospitalized for NSTE-ACS within the preceding 48 h
• have one of the following additional criteria:
• ischemic symptoms at rest, lasting ≥10 minutes;
• horizontal or down-sloping ST segment depression ≥0.1 mV;
• cardiac troponin I (cTnI), marker associated with NSTE-ACS, local laboratory upper limit of normal values;
• underwent percutaneous coronary intervention (PCI); (5) a history of myocardial infarction.

You may not qualify if…

• ST-elevation ACS;
• planned use of glycoprotein IIb/IIIa receptor inhibitors, adenosine diphosphate (ADP) receptor antagonists, or anticoagulant therapy during the study period;
• platelet count <100g/L;
• creatinine clearance rate < 30ml/min;
• diagnosed as respiratory or circulatory instability (cardiac shock, severe congestive heart failure NYHA II-IV or left ventricular ejection fraction < 40%);
• a history of bleeding tendency;
• aspirin, ticagrelor or clopidogrel allergies;
• diabetes.

Where it is running

• VerifyNow — San Diego, California, United States (enrolling)

Full record on ClinicalTrials.gov

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