Recruiting
Phase 2
Phase 3

Ticagrelor

Sponsor:

First Affiliated Hospital of Harbin Medical University

Code:

NCT02889549

Conditions

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

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 have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for ACS patients. However, few East Asian patients 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. But it is still not clear whether a low dose of ticagrelor is superior to clopidogrel in diabetic patients with stable coronary disease.

Recent studies found that antiplatelet drugs might have anti-inflammatory effects and protect endothelial function. ACS patients treated by ticagrelor had a significantly higher increase in levels of circulating progenitor cells compared to those treated by clopidogrel, suggesting a benefit on endothelial regeneration that may participate in the pleiotropic property of the drug. This may prompt the regression of blood vessels and the endothelium stability. But it is not very clear that the effect of low-dose ticagrelor on vascular endothelial function in diabetic patients with stable coronary artery disease.

Therefore, the investigators performed this randomized, single-blind clinical trial to observe the effects of different doses of ticagrelor and standard-dose clopidogrel on platelet aggregation and endothelial function in diabetic patients with stable coronary artery disease.

Conditions

Coronary Artery Disease

Study ID

NCT02889549

Start date

Aug, 2016

Status verified date

Aug, 2016

Primary completion date

Oct, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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)
2. Diabetes

Exclusion Criteria:

1. ACS
2. planned use of glycoprotein IIb/IIIa receptor inhibitors, adenosine diphosphate (ADP) receptor antagonists, aspirin 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. ticagrelor or clopidogrel allergies

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Ticagrelor 22.5 mg

Ticagrelor (22.5 mg, twice daily, oral) treatment for 1 month.

experimental: Ticagrelor 45 mg

Ticagrelor (45 mg, twice daily, oral) treatment for 1 month.

experimental: Ticagrelor 90 mg

Ticagrelor (90 mg, twice daily, oral) treatment for 1 month.

active comparator: Clopidogrel

Clopidogrel (75mg, once daily, oral) treatment for 1 month.

Interventions

ticagrelor

Different doses of ticagrelor (22.5/45/90 mg, twice daily, oral) treatment for 1 month

clopidogrel

Standard dose of clopidogrel (75 mg, once daily, oral) treatment for 1 month

Primary outcome measure

  • Inhibition of platelet aggregation [ Time Frame: up to 1 month ]

Central Contacts and Locations

Locations

VerifyNow

Recruiting

San Diego, California, United States, 92101-92117

Contacts

More Information

Sponsor

First Affiliated Hospital of Harbin Medical University

Last update posted

Feb 23, 2017

Last verified

Aug, 2016

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 2017-02-23.