Clinical trial NCT03048019: Antiplatelet Effects of Tirofiban vs. Cangrelor N-STEMI Patients Undergoing Percutaneous Coronary Intervention
Official title: Comparison of Pharmacodynamic Effects of Tirofiban vs. Cangrelor in N-STEMI Patients Undergoing Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Non-ST Elevation Myocardial Infarction (NSTEMI)
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will consist of NSTEMI patients undergoing percutaneous coronary intervention (PCI): 30 patients each will be treated with tirofiban or cangrelor (total n=60).

Brief summary: Immediate potent inhibition of platelet function is critical for the prevention of periprocedural ischemic event occurrences in high risk N-ST segment elevation myocardial infarction (NSTEMI) in patients undergoing percutaneous coronary intervention (PCI). Currently, dual antiplatelet therapy with aspirin and an oral P2Y12 receptor blocker (with loading doses) is widely used for PCI. However, immediate, potent and reversible inhibition of platelet aggregation is not possible even with the newer oral agents, prasugrel and ticagrelor. Therefore, an intravenously administered GPIIb/IIIa receptor inhibitor (tirofiban) or P2Y12 receptor blocker (cangrelor) with fast onset and offset of actions will provide more desired antiplatelet effects in the setting of PCI. This study will measure and compare the anti-platelet effects of Tirofiban and Cangrelor in patients presenting with N-STEMI and undergoing PCI.


Eligibility criteria: Inclusion Criteria:

1. 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Thrombin Receptor Activator Peptide (TRAP) Induced Platelet Aggregation (%)
timeFrame: 30 minutes post-start of the infusion
Secondary outcomes:
measure: Adenosine Diphosphate (ADP) Induced Platelet Aggregation (%)
timeFrame: 30 minutes post-start of the infusion
measure: Thrombin Induced Platelet-fibrin Clot Strength (mm)
timeFrame: 30 minutes post-start of the infusion
measure: Shear-induced Thrombus Formation (AUC)
timeFrame: 30 minutes after the end of the infusion.
Other outcomes:
Locations:
city: Falls Church
country: United States
facility: Inova Health Care System
state: Virginia
Study officials:
affiliation: Inova Health Care Services
name: Paul Gurbel, MD
role: PRINCIPAL_INVESTIGATOR
References: