Clinical Trial: Ticagrelor Versus Clopidogrel and Eptifibatide Bolus

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Ticagrelor Versus Clopidogrel and Eptifibatide Bolus in Patients With Stable or Unstable Angina Undergoing Coronary Intervention: A Randomized Pharmacodynamic Study

Brief Summary: The purpose of this study is to compare the inhibition of platelet aggregation (i) ticagrelor and bivalirudin/heparin versus (ii) clopidogrel, eptifibatide and heparin in patients with unstable angina undergoing coronary intervention.

Detailed Summary:

The first 30 minutes of PCI procedure is of outmost importance when plaque ruptures and platelet activation occurs. Platelet activation and accumulation causes the formation of blood clots that may cause heart attack. As a standard of care, the doctor can prescribe medications such as are ticagrelor, eptifibatide, clopidogrel, to prevent the formation of blood clots.

100 patients with stable or unstable angina, both male and female, will be randomized to either Group A- Ticagrelor and bivalirudin/heparin or Group B- Clopidogrel, eptifibatide and heparin administrated immediately before PCI. Platelet function testing and ECG will be performed.


Sponsor: University of Alabama at Birmingham

Current Primary Outcome: Change in Platelet Function Testing [ Time Frame: 5 times (baseline, 30 min, 2 h and 4h, and 2 h) ]

The primary end-point of the study is to compare a CHANGE in the percentage of inhibition of platelet aggregation (%IPA) at 2 h comparing ticagrelor and bivalirudin or heparin (Group 1) vs. Clopidogrel, eptifibatide bolus, and heparin (Group 2). We will do a non-inferiority analysis to demonstrate that %IPA at 2 h with ticagrelor and bivalirudin or heparin will be non-inferior to that of clopidogrel and eptifabtide bolus and heparin.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Alabama at Birmingham

Dates:
Date Received: September 27, 2016
Date Started: September 2016
Date Completion: December 2023
Last Updated: October 4, 2016
Last Verified: October 2016