Arachidonic Acid-induced Platelet Aggregation Rate in Patients With Stable CAD Treated With Ticagrelor Monotherapy

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study was a feasibility trial that was designed to provide preliminary observations and generate hypotheses for future studies. The aim of the study is to estimate the difference of arachidonic acid induced platelet aggregation rate between ticagrelor mono-therapy and aspirin/ticagrelor dual-therapy after 14 days of treatment in patients with stable coronary artery disease. The potential hypothesis is that the arachidonic acid (AA) induced platelet aggregation rate after 2 weeks of ticagrelor mono-therapy is comparable to that of aspirin/ticagrelor dual-therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yong Huo
• Treatments: Aspirin; Ticagrelor

Criteria

Inclusion Criteria:

• Provision of informed consent prior to any study specific procedures.

• Aged >18 years.

• Documented stable coronary artery disease.

• Currently receiving dual-antiplatelet therapy with aspirin 100mg/d and clopidogrel 75mg/d.

Exclusion Criteria:

• History of acute coronary syndrome within 12 months of screening.

• History of percutaneous coronary intervention within 12 months of screening.

• Any indication (eg, atrial fibrillation,prosthetic heart valve, or coronary stent) for antithrombotic therapy(eg, warfarin, clopidogrel, or aspirin dose other than 75 to 100 mg/during the study period).

• AA induced platelet aggregation rate >20% on aspirin+clopidogrel measured by light transmission platelet aggregation test with the past 3 months.

• Congestive heart failure or left ventricular ejection fraction <35%.

• Forced expiratory volume in the first second forced vital capacity below the lower limits of normal.

• Bleeding diathesis or severe pulmonary disease.

• Active pathological bleeding.

• History of intracranial hemorrhage.

• Hypersensitivity to ticagrelor or any of the excipients.

• Severe hepatic impairment.

• Pregnancy.

• Current smoking.

• Platelet count <100 000/mm3 or hemoglobin <10 g/dL.

• HemoglobinA1c >10%.

• History of drug addiction or alcohol abuse in the past 2 years.

• Need for nonsteroidal anti-inflammatory drug.

• Creatinine clearance<30 mL/min.

• Concomitant therapy with moderate or strong cytochrome P450 3A inhibitors, substrates, or strong cytochrome P450 3A inducers.