Low-dose of Ticagrelor and Standard-dose Clopidogrel on Platelet Effects in Chinese Patients With Stable CAD.

NCT03679091 | Completed Phase 4 DMC

• 1 other identifier: CHD-201845
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Ticagrelor has been demonstrated to provide a more rapid and more powerful inhibition of platelet aggregation compared with clopidogrel in coronary artery disease (CAD) patients. However, current guidelines recommend ticagrelor 90 mg twice daily might not be suitable for patients of Chinese. Therefore, the investigators performed this study to observe the efficacy of 60-mg ticagrelor in comparison to 75-mg clopidogrel in Chinese patients with stable CAD.

Conditions

Platelet Reactivity

Keywords

Ticagrelor; clopidogrel; coronary artery disease; platelet reactivity

Outcome Measures

Primary Outcomes (1)

• The platelet inhibition ratio.

  Verifynow was used to measure platelet inhibition ratio.

  up to 2 months

Secondary Outcomes (1)

• The platelet aggregation ratio.

  up to 2 months

Study Arms (2)

low-dose ticagrelor

EXPERIMENTAL

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

Drug: low-dose ticagrelor; Drug: Clopidogrel

clopidogrel

ACTIVE COMPARATOR

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

Drug: low-dose ticagrelor; Drug: Clopidogrel

Interventions

low-dose ticagrelor DRUG

low-dose ticagrelor (60.0 mg once daily) for 7 days,followed by a 2-week washout period then a 7 days crossover phase of clopidogrel (75mg once daily).

clopidogrel; low-dose ticagrelor

Clopidogrel DRUG

clopidogrel (75mg once daily) for 7 days,followed by a 2-week washout period then a 7 days crossover phase of low-dose ticagrelor (60.0 mg once daily).

clopidogrel; low-dose ticagrelor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients were eligible to participate if they were aged ≥18 years and ≤ 75 Years
• Subjects had documented stable CAD (defned as stable angina pectoris and objective evidence of CAD, a previous MI, or previous revascularization with percutaneous coronary intervention or coronary artery bypass grafting)
• Women were required to be postmenopausal or surgically sterile
• Patients who were taking clopidogrel or ticagrelor were required to discontinue these agents at least 14 days before randomization

You may not qualify if:

• Acute coronary syndrome (ACS)
• 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/ul
• 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
• allergy to aspirin, ticagrelor or clopidogrel
• diabetes patients

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

VerifyNow

Harbin, California, 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, professor

  First Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 20, 2018
• Study Start: August 29, 2018
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: December 21, 2021

Record last verified: 2021-12

Locations

CN (1)