Low-dose Ticagrelor in Chinese ACS Patients Undergoing PCI

NCT03381755 | Unknown Phase 4

• 1 other identifier: ACS-3
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (2)

• thromboela-stogram

  inhibition of platelet aggregation (ADP) ; MA (ADP)

  up to 6 months

• thromboela-stogram

  inhibition of platelet aggregation; MA

  up to 1 year

Secondary Outcomes (3)

• MACE

  up to 1 year

• Side effects including bleeding and dyspnea

  up to 1 year

• The rate of treatment interruption due to ticagrelor intolerance.

  up to 1 year

Study Arms (2)

half-dose ticagrelor

EXPERIMENTAL

Drug: half-dose ticagrelor

standard-dose ticagrelor

ACTIVE COMPARATOR

Drug: standard-dose ticagrelor

Interventions

half-dose ticagrelor DRUG

To observe the effectiveness and safety of ticagrelor 45mg bidpo. in Chinese ACS patients undergoing PCI.

half-dose ticagrelor

standard-dose ticagrelor DRUG

To observe the effectiveness and safety of ticagrelor 90mg bidpo. in Chinese ACS patients undergoing PCI.

standard-dose ticagrelor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

Thromboela-Stogram

Beijing, Beijing Municipality, 100001, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Yue Li, PhD

  Cardiovascular Department, the First Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guangzhong Liu, PhD

CONTACT

86-451-85555673; lgz2700@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 22, 2017
• Study Start: January 1, 2018
• Primary Completion: December 14, 2019
• Study Completion: December 14, 2020
• Last Updated: September 12, 2018

Record last verified: 2017-12

Locations

CN (1)