Comparing Ticagrelor and Clopidogrel Pharmacodynamics After Thrombolysis (TACAT)
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|ClinicalTrials.gov Identifier: NCT02048085|
Recruitment Status : Withdrawn (unable to get study up and enrolling)
First Posted : January 29, 2014
Last Update Posted : April 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute ST Segment Elevation Myocardial Infarction Acute Coronary Syndrome||Drug: Ticagrelor Drug: Clopidogrel||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Randomized, Open Label, Pilot Study to Assess the Pharmacodynamics Using Vefiynow and VASP Assay; and Pharmacokinetics of Ticagrelor vs Clopidogrel in Patients Undergoing PCI With History of Fibrinolysis in 24-48 Hours|
|Estimated Study Start Date :||January 2, 2014|
|Estimated Primary Completion Date :||May 2015|
|Estimated Study Completion Date :||March 2018|
Ticagrelor Arm will be dosed with a loading dose of 180 mg followed by maintenance dose of 90 mg BID until discharge or up to 8 days.
For ticagrelor arm, randomized STEMI patients with a history of fibrinolysis within last 24-48 and undergoing PCI will be loaded with ticagrelor 180 mg prior to PCI followed by maintenance dose of 90 mg bid.
Other Name: Brilinta
Active Comparator: Clopidogrel
Clopidogrel arm will be dose with a loading dose of 300 mg followed by maintenance dose of 75 mg everyday until discharge or up to 8 days.
For clopdigrel arm, randomized STEMI patients with a history of fibrinolysis within last 24-48 and undergoing PCI will be loaded with clopidogrel 300 mg prior to PCI followed by maintenance dose of 75 mg QD
Other Name: Plavix
- Pharmacodynamics (PRU and IPA) of ticagrelor vs Clopidogrel using VASP and VerifyNow [ Time Frame: Change from baseline at 2 hours ]Pharmacodynamics at baseline, 30 min, 60 min, 120 min, 4 hours, 8 hours and at 24 hours
- Pharmacokinetic (AUC, Cmax, Tmax) [ Time Frame: Change from baseline at 2 hours ]Pharmacokinetics at baseline, 30 min, 60 min, 120 min, 4 hours, 8 hours and at 24 hours
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02048085
|United States, Arkansas|
|Medical Center of South Arkansas|
|El Dorado, Arkansas, United States, 71730|
|Principal Investigator:||Rakesh K Sharma, MD, FACC, FSCAI, FSCCT||Medical Center of South Arkansas|