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

NCT03048019 | Terminated Results FDA Drug

• 1 other identifier: 17-2617
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-ST Elevation Myocardial Infarction (NSTEMI)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Adenosine Diphosphate (ADP) Induced Platelet Aggregation (%)

  30 minutes post-start of the infusion

• Thrombin Induced Platelet-fibrin Clot Strength (mm)

  30 minutes post-start of the infusion

• Shear-induced Thrombus Formation (AUC)

  30 minutes after the end of the infusion.

Study Arms (2)

Tirofiban Therapy

patients randomized to tirofiban therapy

Drug: Tirofiban

Cangrelor Therapy

patients randomized to cangrelor therapy

Drug: Cangrelor

Interventions

Tirofiban DRUG

Patients will receive Tirofiban during the PCI procedure

Also known as: Aggrastat

Tirofiban Therapy

Cangrelor DRUG

Patients will receive Cangrelor during the PCI procedure

Also known as: Kengreal

Cangrelor Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• \. NSTEMI meeting the following criteria:
• 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
• Eligible for ticagrelor, cangrelor, aspirin, UFH, and GP IIb/IIIa inhibitor treatment.
• Admitted at cardiac catheterization laboratory hospital or associated facility.
• Competent mental condition to provide informed consent.

You may not qualify if:

• Unstable angina, STEMI
• Cardiogenic shock
• Refractory ventricular arrhythmias
• New York Heart Association class IV congestive heart failure
• Cardiac arrest within 1 week of study entry
• History of hemorrhagic or ischemic stroke, TIA, sub-arachnoid hemorrhage or intracranial neoplasm, arteriovenous malformation, or aneurysm
• Fibrinolytic therapy within 48 hours of study entry
• Active pathological bleeding or history of bleeding diathesis
• Severe hepatic insufficiency
• Current peptic ulceration
• Increased bleeding risk, per investigator judgment
• Known anemia (hematocrit\<25%)/thrombocytopenia (platelet count \< 100,000mm3)
• Surgery within 4 weeks before study entry or planned surgery within 2 months after study entry
• Any P2Y12 receptor inhibitor or GP IIb/IIIa inhibitor within 7 days of study entry
• 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

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

Inova Health Care System

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction

Interventions

Tirofiban; cangrelor

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Sinai Center for Thrombosis Research

kbliden@lifebridgehealth.org

443-244-1497

Study Officials

• Paul Gurbel, MD

  Inova Health Care Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 9, 2017
• Study Start: August 23, 2017
• Primary Completion: June 27, 2019
• Study Completion: June 27, 2019
• Last Updated: December 11, 2023
• Results First Posted: December 11, 2023

Record last verified: 2023-12

Locations

US (1)