Effects of Different Doses of Ticagrelor on Platelet Aggregation and Endothelial Function in Diabetic Patients With Stable Coronary Artery Disease

NCT02889549 | Unknown Phase 2

• 1 other identifier: SCAD-20160901
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

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 have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for ACS patients. However, few East Asian patients have been included in these trials to assess the use of these drugs. In addition, a growing body of data supported that East Asian might have different adverse event profiles (thrombophilia and bleeding) and "therapeutic window" compared with white subjects. But it is still not clear whether a low dose of ticagrelor is superior to clopidogrel in diabetic patients with stable coronary disease. Recent studies found that antiplatelet drugs might have anti-inflammatory effects and protect endothelial function. ACS patients treated by ticagrelor had a significantly higher increase in levels of circulating progenitor cells compared to those treated by clopidogrel, suggesting a benefit on endothelial regeneration that may participate in the pleiotropic property of the drug. This may prompt the regression of blood vessels and the endothelium stability. But it is not very clear that the effect of low-dose ticagrelor on vascular endothelial function in diabetic patients with stable coronary artery disease. Therefore, the investigators performed this randomized, single-blind clinical trial to observe the effects of different doses of ticagrelor and standard-dose clopidogrel on platelet aggregation and endothelial function in diabetic patients with stable coronary artery disease.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Inhibition of platelet aggregation

  up to 1 month

Secondary Outcomes (1)

• Endothelial Function

  up to 1 month

Study Arms (4)

Ticagrelor 22.5 mg

EXPERIMENTAL

Ticagrelor (22.5 mg, twice daily, oral) treatment for 1 month.

Drug: ticagrelor

Ticagrelor 45 mg

EXPERIMENTAL

Ticagrelor (45 mg, twice daily, oral) treatment for 1 month.

Drug: ticagrelor

Ticagrelor 90 mg

EXPERIMENTAL

Ticagrelor (90 mg, twice daily, oral) treatment for 1 month.

Drug: ticagrelor

Clopidogrel

ACTIVE COMPARATOR

Clopidogrel (75mg, once daily, oral) treatment for 1 month.

Drug: clopidogrel

Interventions

ticagrelor DRUG

Different doses of ticagrelor (22.5/45/90 mg, twice daily, oral) treatment for 1 month

Ticagrelor 22.5 mg; Ticagrelor 45 mg; Ticagrelor 90 mg

clopidogrel DRUG

Standard dose of clopidogrel (75 mg, once daily, oral) treatment for 1 month

Clopidogrel

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 (1) stable angina (2) low-risk unstable angina (3) variant angina (4) patients with asymptomatic with appropriate therapy（including percutaneous coronary intervention）
• Diabetes

You may not qualify if:

• ACS
• planned use of glycoprotein IIb/IIIa receptor inhibitors, adenosine diphosphate (ADP) receptor antagonists, aspirin 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
• ticagrelor or clopidogrel allergies

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (2)

VerifyNow

San Diego, California, 92101-92117, United States

RECRUITING

Endothelial Function detection by brachial artery ultrasound

Harbin, China

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

Central Study Contacts

Meijiao He, MM

CONTACT

86-451-85555672; hemeijiao99@sina.com

Yue Li, PHD

CONTACT

86-451-85555673; ly99ly@vip.163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 5, 2016
• Study Start: August 1, 2016
• Primary Completion: October 1, 2017
• Last Updated: February 23, 2017

Record last verified: 2016-08

Locations

US (1); CN (1)