Safety and Efficacy of Low-dose Ticagrelor in Chinese Patients With Stable Coronary Artery Disease

NCT02514642 | Unknown Phase 4 DMC

• 1 other identifier: SCAD-201523
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• P2Y12 reaction units (PRU)

  up to 5 months

Secondary Outcomes (1)

• inhibition of platelet aggregation (IPA)

  up to 5 months

Study Arms (2)

low-dose ticagrelor

EXPERIMENTAL

To observe the safety and efficacy of low-dose ticagrelor in Chinese patients withStable Coronary Artery Disease

Drug: low-dose ticagrelor; Drug: Clopidogrel

clopidogrel

ACTIVE COMPARATOR

To observe the different safety and efficacy between low-dose ticagrelor and conventional-dose clopidogrel.

Drug: low-dose ticagrelor; Drug: Clopidogrel

Interventions

low-dose ticagrelor DRUG

low-dose ticagrelor (22.5 mg twice daily) for 7 days,followed by a 2-week washout period then a 7days crossover phase of clopidogrel (75mg once daily)

Also known as: low-dose ticagrelor(22.5 mg twice daily)

clopidogrel; low-dose ticagrelor

Clopidogrel DRUG

clopidogrel (75mg once daily) for 7 days,followed by a 2-week washout period then a 7days crossover phase of low-dose ticagrelor (22.5 mg twice daily)

Also known as: clopidogrel (75mg once daily)

clopidogrel; low-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:

• Stable Coronary Artery Disease
• stable angina
• low-risk unstable angina
• variant angina
• patients with asymptomatic with appropriate therapy（including percutaneous coronary intervention）.

You may not qualify if:

• ACS
• planned use of glycoprotein IIb/IIIa receptor inhibitors, adenosine diphosphate (ADP) receptor antagonists, or anticoagulant therapy during the study period
• platelet count \<100g/L
• creatinine clearance rate \< 30ml/min
• diagnosed as respiratory or circulatory instability (cardiac shock, severe congestive heart failure NYHA II-IV or left ventricular ejection fraction \< 40%)
• a history of bleeding tendency
• aspirin, ticagrelor or clopidogrel allergies
• diabetes.

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

VerifyNow

San Diego, California, 92101-92117, United States

RECRUITING

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, MD

  Cardiovascular Department, the First Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meijiao He, MM

CONTACT

86-451 -85555673; hemeijiao99@sina.com

Study Design

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

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: August 4, 2015
• Study Start: July 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: September 30, 2015

Record last verified: 2015-07

Locations

US (1)