A Randomized, Controlled, Open Label Trial Comparing the Ischemic Preconditioning Effects of Ticagrelor and Clopidogrel in Humans

Study ID
STU 122012-033

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern-Clinical Translational Research Center (CTRC)
  • Clements University Hospital
  • Dallas Veteran's Affairs Medical Center
  • Parkland Health & Hospital System

Contact
Sheikh Vikarunnessa
214-648-9261
sheikh.vikarunnessa@utsouthwestern.edu

Principal Investigator
Michael Luna

Summary

We propose a prospective, randomized open label trial that will randomize 30 patients undergoing clinically-indicated coronary angiography, and found to have single or two or three vessel coronary artery disease, to clopidogrel (600 mg loading dose, 75 mg daily maintenance dose) or ticagrelor (180 mg loading dose, 90 mg twice daily maintenance dose). after allowing 7-12 days to achieve drug stead state, all patients will return for repeat cardiac catheterization and completion of study protocol, followed by standard PCi. as part of the protocol, all patients will undergo balloon occlusion of the target vessel within the target lesion to determine whether, compared to clopidogrel, ticagrelor will result in improved tolerance of ischemia as measured by:
(1) Degree of ST-segment elevation by intracoronary eKG (primary endpoint)
(2) Degree of ST-segment elevation by surface eKG (secondary endpoint)
(3) Maximum inflation time tolerated (MiTT, secondary endpoint)
(4) Time to ST-segment elevation (secondary endpoint)
(5) angina score (secondary endpoint)
(6) Wall motion and strain rate on chest wall echocardiography (secondary endpoints)

Participant Eligibility

1. Undergoing clinically-indicated PCI for stable or progressive exertional angina without rest angina, ST segment shift, or elevated CK-MB or troponin-T or I
2. Willing and able to give informed consent and to comply with study procedures
3. Found to have single or two-vessel or three vessel obstructive, non-occlusive (>= 70% but < 100% stenosis), coronary artery disease with plans for treatment of all lesions by PCI
4. Target lesion location in the proximal or mid coronary vessel with reference diameter >= 2.5 mm