Clinical Trial Details
| Trial ID: | L1526 |
| Source ID: | NCT02578537 |
| Associated Drug: | Ticagrelor |
| Title: | COmparison of the Pharmacodynamics and Pharmacokinetics Ticagrelor Versus Clopidogrel in Patients With CKD and NSTE-ACS |
| Acronym: | OPT-CKD |
| Status: | UNKNOWN |
| Study Results: | NO |
| Results: | |
| Conditions: | Non ST Segment Elevation Acute Coronary Syndrome|Chronic Kidney Disease |
| Interventions: | DRUG: Ticagrelor|DRUG: Clopidogrel |
| Outcome Measures: | Primary: PRU assayed by VerifyNow, 30 days after loading does of study drug | Secondary: PRU assayed by VerifyNow, at the time of pre-dose, and 2 hours, 8 hours, and 24 hours after loading dose of study durg.|Index of Platelet activity, calculated by the change of the P2Y12 reaction units (PRU) from baseline, at the time of 2 hours, 8 hours, and 24 hours after loading dose of study drug|Rate of high on-treatment platelet reactivity (HPR), at the time of pre-dose, and 2 hours, 8 hours, 24 hours and 30 days after loading dose of study durg.|Plasma concentration of ticagrelor and clopidogrel, at 2 hours, 8 hours, and 24 hours after loading dose of study durg.|Bleeding events, by BARC classification, 30 days after loading does of study drug |
| Sponsor/Collaborators: | Sponsor: Shenyang Northern Hospital |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 60 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2015-10 |
| Completion Date: | 2016-07 |
| Results First Posted: | |
| Last Update Posted: | 2015-12-11 |
| Locations: | Shenyang Northern Hospital, Shenyang, Liaoning, 110016, China |
| URL: | https://clinicaltrials.gov/show/NCT02578537 |
