Recruiting

Ticagrelor

Sponsor:

First Affiliated Hospital of Harbin Medical University

Code:

NCT02514642

Conditions

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

low-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. 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 Korea and Japan, it has been reported that low doses of ticagrelor might have a more potent inhibition of platelet aggregation (IPA) than clopidogrel (75 mg once daily) in healthy subjects and patients with stable coronary artery disease, respectively. But it is still not clear whether a low dose of ticagrelor is superior to clopidogrel in a large population of Chinese ACS patients. A recent study on pharmacokinetics and tolerability of ticagrelor has found that maximum plasma concentration and area under the plasma concentration-time curve of ticagrelor (90 mg twice daily) and its active metabolite (AR-C124910XX) tended to be approximately 40% higher in healthy Chinese volunteers compared with Caucasian subjects. This data also suggested that a low dose of ticagrelor might be more appropriate for Chinese ACS patients. In view of a large diurnal variation with a single daily dose, a lower dose twice daily may be a better choice for Chinese patients. Therefore, the investigators performed this randomized, single-blind, crossover clinical trial to observe the efficacy and safety of low-dose ticagrelor (22.5 mg twice daily) in comparison to clopidogrel (75mg once daily) in Chinese patients with stable coronary artery disease.

Conditions

Coronary Artery Disease

Study ID

NCT02514642

Start date

Jul, 2015

Status verified date

Jul, 2015

Completion date

Nov, 2015

Anticipated

Primary completion date

Oct, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Stable Coronary Artery Disease

1. stable angina
2. low-risk unstable angina
3. variant angina
4. patients with asymptomatic with appropriate therapy(including percutaneous coronary intervention).

Exclusion Criteria:

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

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 withStable Coronary Artery Disease

active comparator: clopidogrel

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

Interventions

low-dose ticagrelor

low-dose ticagrelor (22.5 mg twice daily) for 7 days,followed by a 2-week washout period then a 7days crossover phase of clopidogrel (75mg once daily)

Clopidogrel

clopidogrel (75mg once daily) for 7 days,followed by a 2-week washout period then a 7days crossover phase of low-dose ticagrelor (22.5 mg twice daily)

Primary outcome measure

  • P2Y12 reaction units (PRU) [ Time Frame: up to 5 months ]

Central Contacts and Locations

Central contacts

Locations

VerifyNow

Recruiting

San Diego, California, United States, 92101-92117

Contacts

More Information

Sponsor

First Affiliated Hospital of Harbin Medical University

Last update posted

Sep 30, 2015

Last verified

Jul, 2015

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 2015-09-30.