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Tirofiban vs Cangrelor Study

General Information

Age Group

Adult

Status

Active

Protocol Number

17-2617

Background Information

Coronary artery disease develops when blood vessels that supply the heart with oxygen and nutrients (coronary arteries) become damaged or diseased by cholesterol-containing deposits (atherosclerotic plaque) in the arteries. When plaques build up, they narrow the coronary arteries, decreasing blood flow to the heart, which may cause chest pain, shortness of breath, or other heart problems. If the plaque breaks or ruptures, it causes injury on the inside wall of the affected artery. As a response to the injury, blood cell fragments (called platelets) clump at the site to form a blood clot within the artery causing a blockage. A complete blockage can cause a heart attack.

A procedure called Percutaneous Coronary Intervention (PCI) is done to open up the narrowed or blocked artery using a balloon (angioplasty) that compresses the plaque against the artery wall, a placement of a stent (a metal mesh to hold open the blocked artery), a procedure to remove the clot (thrombectomy), or a combination of any of these procedures.

Sometimes, a blood clot can form inside the injured blood vessel while undergoing PCI. This blood clot can lead to another heart attack or stroke. To lower this risk, medications such as Integrilin® (eptifibatide), Aggrastat ® (tirofiban), or Kengreal ® (cangrelor) may be administered through a vein during the procedure. Integrilin, tirofiban, and cangrelor are antiplatelet medications approved by the U.S. Food and Drug Administration for patients with heart attack who are undergoing a PCI procedure. Antiplatelet medications prevent platelets from sticking together and forming harmful blood clots.

This research study is being done to assess which antiplatelet drug, tirofiban or cangrelor, works better to prevent platelets from clumping together and forming blood clots in patients undergoing PCI.

Offered At

Inova Center for Thrombosis Research and Drug Development, Inova Heart and Vascular Institute

3300 Gallows Road

Falls Church, VA 22042

Eligibility Information

NSTEMI meeting the following criteria:

  1. Patients 18 years of age or older with one or more of the following symptoms:
    • new ST-segment depression or transient elevation of at least 1 mm
    • elevations in troponin I, troponin T, or creatine kinase MB levels above ULN
  2. Eligible for ticagrelor, cangrelor, aspirin, UFH, and GP IIb/IIIa inhibitor treatment.
  3. Admitted at cardiac catheterization laboratory hospital or associated facility.
  4. Competent mental condition to provide informed consent.

Ineligibility Information

  1. Unstable angina, STEMI
  2. Cardiogenic shock
  3. Refractory ventricular arrhythmias
  4. New York Heart Association class IV congestive heart failure
  5. Cardiac arrest within 1 week of study entry
  6. History of hemorrhagic or ischemic stroke, TIA, sub-arachnoid hemorrhage or intracranial neoplasm, arteriovenous malformation, or aneurysm
  7. Fibrinolytic therapy within 48 hours of study entry
  8. Active pathological bleeding or history of bleeding diathesis
  9. Severe hepatic insufficiency
  10. Current peptic ulceration
  11. Increased bleeding risk, per investigator judgment
  12. Known anemia (hematocrit<25%)/thrombocytopenia (platelet count < 100,000mm3)
  13. Surgery within 4 weeks before study entry or planned surgery within 2 months after study entry
  14. Any P2Y12 receptor inhibitor or GP IIb/IIIa inhibitor within 7 days of study entry
  15. Receiving warfarin or other coumadin derivatives or NOACs within the last 10 days with an INR >1.5 secs or planned use during the hospitalization period
  16. Contraindication to the use of ticagrelor and/or aspirin
  17. Receiving or will receive oral anticoagulation or other oral antiplatelet therapy (except aspirin) that cannot be safely discontinued within the next 3 months
  18. Receiving daily NSAIDs or COX2 inhibitors that cannot be discontinued or anticipated to require >2 weeks of daily NSAIDs or COX2 inhibitors during study
  19. Investigational drug in last 30 days or presently enrolled in drug/device study
  20. Women of childbearing potential (post-menopausal women can be enrolled if at least 1 year of amenorrhea or surgically sterile)
  21. Condition associated with poor treatment compliance (e.g., alcoholism, mental illness, or drug dependence)
  22. Inability to provide written informed consent and to understand the full meaning of the informed consent