Reversal of the Anti-platelet Effects of Ticagrelor

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the proportion of untreated donor platelets required to fully reverse the platelet inhibitory effects of ticagrelor and aspirin in healthy persons and patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) and receiving ticagrelor.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Collaborator: National Natural Science Foundation of China
• Treatments: Aspirin; Ticagrelor

Criteria

Cohort 1:

Inclusion Criteria:

• Healthy volunteers;

• Subjects aged >18 years old;

Exclusion Criteria:

• Allergy or intolerance to aspirin or ticagrelor;

• Subjects at a high risk of bleeding (e.g. platelet count<100×10^9/L, history of peptic ulcer, hemoglobin<110g/L);

• Subjects with anemia;

• Subjects with bronchial asthma or chronic obstructive pulmonary disease;

• Subjects with bradycardia (e.g. sick sinus syndrome, high-grade atrioventricular block, history of syncope with unproved uncorrelation with bradycardia);

• Smokers;

• Subjects with diabetes mellitus;

• Subjects planning to be pregnancy;

• Subjects with hepatic or renal dysfunction;

• Subjects who have taken other anti-platelet drugs, non-steroidal anti-inflammatory drugs or proton pump inhibitors before scanning or need to take them during study period.

Cohort 2:

Inclusion Criteria:

• Subjects with diagnosed coronary artery disease undergoing percutaneous coronary intervention (PCI);

• Subjects who have received dual anti-platelet therapy (ticagrelor 90mg bid + aspirin 100mg daily) for 7 days;

Exclusion Criteria:

• Subjects at a high risk of bleeding (e.g. platelet count<100×10^9/L, history of peptic ulcer, hemoglobin<110g/L);

• Subjects with anemia;

• Smokers

• Subjects planning to be pregnancy;

• Subjects with hepatic or renal dysfunction;

• Subjects who have taken other anti-platelet drugs, non-steroidal anti-inflammatory drugs or proton pump inhibitors before scanning or need to take them during study period.