Antiplatelet Effects of Tirofiban vs. Cangrelor N-STEMI Patients Undergoing Percutaneous Coronary Intervention

Non-ST Elevation Myocardial Infarction (NSTEMI) Clinical Trial

Official title:

Comparison of Pharmacodynamic Effects of Tirofiban vs. Cangrelor in N-STEMI Patients Undergoing Percutaneous Coronary Intervention

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03048019
• Other study ID #: 17-2617
• Status: Terminated
• Start date: August 23, 2017
• Est. completion date: June 27, 2019

Study information

• Verified date: December 2023
• Source: Inova Health Care Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: June 27, 2019
• Est. primary completion date: June 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Non-ST Elevated Myocardial Infarction
• Non-ST Elevation Myocardial Infarction (NSTEMI)

Intervention

Drug:
• Tirofiban
Patients will receive Tirofiban during the PCI procedure
• Cangrelor
Patients will receive Cangrelor during the PCI procedure

Locations

Country	Name	City	State
United States	Inova Health Care System	Falls Church	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Inova Health Care Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thrombin Receptor Activator Peptide (TRAP) Induced Platelet Aggregation (%)	Assessment of platelet aggregation (%) in response to 10uM thrombin receptor activator peptide. Normal reference range is 60-100% aggregation.	30 minutes post-start of the infusion
Secondary	Adenosine Diphosphate (ADP) Induced Platelet Aggregation (%)	Assessment of platelet aggregation (%) in response to 20uM ADP at baseline and serially following tirofiban or cangrelor infusion. Normal reference range is 60-100% aggregation.	30 minutes post-start of the infusion
Secondary	Thrombin Induced Platelet-fibrin Clot Strength (mm)	Assessment of thrombin induced platelet-fibrin clot strength (mm) by thromboelastography (TEG6S). Normal reference range is 55-68 mm	30 minutes post-start of the infusion
Secondary	Shear-induced Thrombus Formation (AUC)	Real time evaluation of shear-induced thrombus formation using novel RUO T-TAS plus system. AUC is calculated as time to reach 60 kPa	30 minutes after the end of the infusion.