Reversal of the Anti-platelet Effects of Ticagrelor

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Mar 3, 2015

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ClinConnect Summary

Reversal of the Anti-platelet Effects of Ticagrelor: REVERSAL study

The fatality of stent thrombosis (ST) in patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) is approximately 50% and clopidogrel is an important anti-platelet drug for prevention of ST. CAD patients implanted with stent including bare metal stent (BMS) and drug eluting stent (DES) are recommended to receive dual anti-platelet treatment (DAPT), i.e. clopidogrel along with aspirin, for at least one year to reduce the incidence of ST by up-to-date guidelines. However, due to the va...

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Eligibility 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.