Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT02513004
Status:
UNKNOWN
Last Update Posted:
2017-02-09
First Post:
2015-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Antiplatelet Effects and Safety of Intraoperative Administration of Ticagrelor Versus Clopidogrel
Sponsor:
Yongjian Wu
Organization:
Study Overview
Official Title:
Evaluation of Antiplatelet Effects and Safety of Intraoperative Administration of Ticagrelor Versus Clopidogrel in Patients Undergoing "One-stop" Hybrid Coronary Revascularization
Status:
UNKNOWN
Status Verified Date:
2017-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to test the hypothesis that the onset of the antiplatelet effect 90mg-first-dose of ticagrelor will be more rapid and greater than 300mg-loading-dose of clopidogrel evaluated by P2Y12 reaction units measured by Verify NowTM P2Y12 assay at 1 hour in patients undergoing one-stop Hybrid coronary revascularization(HCR).
Detailed Description:
This is a single-center, randomized, active-controlled, open-label, prospective study, and the study is designed to test the hypothesis that the onset of the antiplatelet effect 90mg-first-dose of ticagrelor will be more rapid and greater than 300mg-loading-dose of clopidogrel evaluated by P2Y12 reaction units (PRU) measured by Verify NowTM P2Y12 assay at 1 hour in patients undergoing one-stop HCR. The first dose of study drug (ticagrelor 90mg or clopidogrel 300 mg) will be administered as powder via a nasogastric tube after confirmation of left internal mammal artery to left anterior descending coronary antery (LIMA-LAD) graft patency during the HCR procedure. Approximately 60 patients will enrol for the study. Patients will be randomized equally (ratio 1:1) to the two treatment arms of this study. The anticipated duration of the study is approximately 15 months, including an anticipated enrolment period of 12 months and follow-up period of 3months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: