Ticagrelor and Clopidogrel on Platelet Effects in Chinese Patients With Stable Coronary Artery Disease

NCT04001894 | Completed Phase 4 DMC

• 1 other identifier: 20190515
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor reduces thrombotic events in patients with coronary artery disease, but these benefits come at the expense of increased risk of bleeding when compared with aspirin monotherapy. Increased evidence showed that P2Y12 inhibitor monotherapy still maintain antiischemic efficacy while reducing the bleeding risk compared with DAPT. Therefore, the investigators performed this study to observe the efficacy of ticagrelor in comparison to clopidogrel in Chinese patients with stable CAD.

Conditions

Platelet Reactivity

Keywords

Ticagrelor; Clopidogrel; Coronary artery disease; platelet function tests

Outcome Measures

Primary Outcomes (1)

• The platelet inhibition ratio

  Thromboelastogram was used to measure platelet inhibition ratio.

  up to 3 months

Secondary Outcomes (1)

• The platelet aggregation ratio.

  up to 3 months

Study Arms (2)

Ticagrelor

EXPERIMENTAL

To observe the safety and efficacy of standard-dose ticagrelor in Chinese patients with Stable Coronary Artery Disease

Drug: Ticagrelor 90mg; Drug: Clopidogrel 75mg

Clopidogrel

ACTIVE COMPARATOR

To observe the safety and efficacy of standard-dose clopidogrel in Chinese patients with Stable Coronary Artery Disease

Drug: Ticagrelor 90mg; Drug: Clopidogrel 75mg

Interventions

Ticagrelor 90mg DRUG

Ticagrelor (90.0 mg twice daily) for 2 weeks, followed by a 2-week washout period then 2 weeks crossover phase of clopidogrel (75mg once daily).

Also known as: Ticagrelor

Clopidogrel; Ticagrelor

Clopidogrel 75mg DRUG

Clopidogrel (75mg once daily) for 2 weeks, followed by a 2-week washout period then 2 weeks crossover phase of ticagrelor (90.0 mg twice daily).

Also known as: Clopidogrel

Clopidogrel; Ticagrelor

Eligibility Criteria

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

You may qualify if:

• Aged ≥18 years
• Subjects had documented with stable CAD
• Women were required to be postmenopausal or surgically sterile
• Patients were required to discontinue clopidogrel or ticagrelor at least 14 days before randomization
• Patients were required to discontinue aspirin at least 14 days before randomization.

You may not qualify if:

• Acute coronary syndrome
• Planned use of glycoprotein IIb/IIIa receptor inhibitors, adenosine diphosphate (ADP) receptor antagonists other than the study medication, or anticoagulant therapy during the study period
• Platelet count \<10×10\^4/μL
• Hstory of bleeding tendency
• Diagnosed as respiratory or circulatory instability
• Allergy to ticagrelor or clopidogrel

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

Thrombelastogram

Harbin, Heilongjiang, 150001, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive 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; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Yue Li, Doctor

  First Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: June 28, 2019
• Study Start: July 2, 2019
• Primary Completion: December 9, 2020
• Study Completion: December 9, 2020
• Last Updated: January 11, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)