Recruiting
Phase 3

Ticagrelor

Sponsor:

First Affiliated Hospital of Harbin Medical University

Code:

NCT02415803

Conditions

Non ST Segment Elevation Acute Coronary Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

low-dose ticagrelor

conventional-dose ticagrelor

Clopidogrel

Study Details

Brief summary:

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).

Conditions

Non ST Segment Elevation Acute Coronary Syndrome

Study ID

NCT02415803

Start date

Dec, 2014

Status verified date

Dec, 2014

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • hospitalized for NSTE-ACS within the preceding 48 h
  • have one of the following additional criteria:

1. ischemic symptoms at rest, lasting ≥10 minutes;
2. horizontal or down-sloping ST segment depression ≥0.1 mV;
3. cardiac troponin I (cTnI), marker associated with NSTE-ACS, local laboratory upper limit of normal values;
4. underwent percutaneous coronary intervention (PCI); (5) a history of myocardial infarction.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: low-dose ticagrelor

To observe the safety and efficacy of low-dose ticagrelor in Chinese patients with non-ST-elevation acute coronary syndrome

active comparator: conventional-dose ticagrelor

To observe the different safety and efficacy between low-dose ticagrelor and conventional-dose ticagrelor.

active comparator: clopidogrel

To observe the different safety and efficacy between low-dose ticagrelor and conventional-dose clopidogrel.

Interventions

low-dose ticagrelor

90 mg loading dose, then 45 mg twice daily for 5 days

conventional-dose ticagrelor

180 mg loading dose, then 90 mg twice daily for 5 days

Clopidogrel

300 mg loading dose, then 75 mg once daily for 5 days

Primary outcome measure

  • the differences in mean inhibition of platelet aggregation or inhibition ratio (%) [ Time Frame: before dosing (baseline) and up to 12 hours after the last dose ]

Central Contacts and Locations

Central contacts

Yue Li, MD

86-451-85555673ly99ly@vip.163.com

Hongjie Xue, MD

86-451-85555672xuehj@163.com

Locations

VerifyNow

Recruiting

San Diego, California, United States, 92101-92117

Contacts

Jing Shi, MM

518-393-2200customerservice@accriva.com

More Information

Sponsor

First Affiliated Hospital of Harbin Medical University

Last update posted

Apr 14, 2015

Last verified

Dec, 2014

Keywords

  • low-dose ticagrelor
  • clopidogrel
  • Chinese patients with NSTE-ACS
  • platelet reactivity
  • inhibition of platelet aggregation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by First Affiliated Hospital of Harbin Medical University on 2015-04-14.