Low-dose Ticagrelor in Chinese ACS Patients Undergoing PCI

Acute Coronary Syndrome Clinical Trial

Official title:

Comparative Effectiveness and Safety Analysis of Low-dose and Standard-dose Ticagrelor in Chinese Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03381755
• Other study ID #: ACS-3
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2018
• Est. completion date: December 14, 2020

Study information

• Verified date: December 2017
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: Guangzhong Liu, PhD
• Phone: 86-451-85555673
• Email: lgz2700[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dual Antiplatelet Therapy (DAPT) with aspirin and P2Y12 receptor inhibitor remains a cornerstone in the secondary prevention of coronary artery disease (CAD). Clopidogrel is one of the most commonly used antithrombotic agent that inhibits the platelet P2Y(12) adenosine diphosphate (ADP) receptor.

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. The previous studies have reported that half-dose ticagrelor had the similar inhibitory effect on platelet aggregation as the standard-dose ticagrelor, which was significantly stronger than that in the clopidogrel group. One-quarter standard-dose ticagrelor provided greater degree of platelet inhibition than standard dose clopidogrel in Chinese patients with stable CAD. But the effectiveness and safety of low-dose ticagrelor remain yet not very clearly in Chinese patients with acute coronary syndrome undergoing percutaneous coronary intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 14, 2020
• Est. primary completion date: December 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• After half-dose ticagrelor (loading dose 90mg, and then 45mg bidpo.) treatment for 3 days, the platelet aggregation is effectively inhibited by light transmission aggregometry method and thromboela-stogram.

• planned to undergo PCI recently

• planned to DAPT for 1 year after PCI

Exclusion Criteria:

• taken adenosine diphosphate (ADP) receptor antagonists within 2 weeks

• Platelet count <100g/L;

• A history of bleeding tendency;

• Aspirin, ticagrelor or clopidogrel allergies;

• Severe liver injury.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• half-dose ticagrelor
To observe the effectiveness and safety of ticagrelor 45mg bidpo. in Chinese ACS patients undergoing PCI.
• standard-dose ticagrelor
To observe the effectiveness and safety of ticagrelor 90mg bidpo. in Chinese ACS patients undergoing PCI.

Locations

Country	Name	City	State
China	Thromboela-Stogram	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	thromboela-stogram	inhibition of platelet aggregation (ADP) ; MA (ADP)	up to 6 months
Primary	thromboela-stogram	inhibition of platelet aggregation; MA	up to 1 year
Secondary	MACE	cardiovascular death, non-fatal myocardial infarction and stroke	up to 1 year
Secondary	Side effects including bleeding and dyspnea		up to 1 year
Secondary	The rate of treatment interruption due to ticagrelor intolerance.		up to 1 year