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P2Y12 Receptor Antagonist

low-dose ticagrelor for Coronary Artery Disease

Phase 4
Waitlist Available
Led By Yue Li, MD
Research Sponsored by First Affiliated Hospital of Harbin Medical University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 months
Awards & highlights

Study 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.

Eligible Conditions
  • Coronary Artery Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
P2Y12 reaction units (PRU)
Secondary outcome measures
inhibition of platelet aggregation (IPA)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: low-dose ticagrelorExperimental Treatment2 Interventions
To observe the safety and efficacy of low-dose ticagrelor in Chinese patients withStable Coronary Artery Disease
Group II: clopidogrelActive Control2 Interventions
To observe the different safety and efficacy between low-dose ticagrelor and conventional-dose clopidogrel.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ticagrelor
FDA approved
Clopidogrel
FDA approved

Find a Location

Who is running the clinical trial?

First Affiliated Hospital of Harbin Medical UniversityLead Sponsor
136 Previous Clinical Trials
1,370,357 Total Patients Enrolled
9 Trials studying Coronary Artery Disease
7,326 Patients Enrolled for Coronary Artery Disease
Yue Li, MDPrincipal InvestigatorCardiovascular Department, the First Affiliated Hospital of Harbin Medical University
1 Previous Clinical Trials
3,043 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
3,043 Patients Enrolled for Coronary Artery Disease

Frequently Asked Questions

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~3 spots leftby Apr 2025