Crushed Ticagrelor Versus Eptifibatide Bolus + Clopidogrel

NCT02925923 | Completed Phase 2 Results

• 1 other identifier: F151006002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with troponin-negative acute coronary syndrome (ACS) are not routinely pre-treated with P2Y12 inhibitors and the rate of high on-treatment platelet reactivity (HPR) remains elevated after a loading dose of ticagrelor at the time of percutaneous coronary intervention (PCI). This suggests that faster platelet inhibition with crushed ticagrelor , eptifibatide , or cangrelor is needed to reduce HPR and periprocedural myocardial infarction and injury (PMI). The present study compared the effects of crushed ticagrelor vs. eptifibatide bolus + clopidogrel in troponin-negative ACS patients undergoing PCI.

Conditions

Acute Coronary Syndrome; Angina, Unstable

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Change in high-on Treatment Platelet Reactivity (HPR)

  We assessed platelet aggregation at baseline and during PCI by light transmission aggregomerty. The primary efficacy measure was HPR defined as platelet aggregation \>59% at 2 h measured by the Chronlog aggregometer after stimulation with ADP 20 µM.

  5 times (at baseline, and at 0.5, 2, 4, and 24 hours after loading dose)

Secondary Outcomes (11)

• Number of Participants With a Periprocedural Myocardial Infarction and Injury (PMI)

  At baseline and every 8 hours post- PCI

• Platelet Aggregation Levels

  At baseline and at 0.5, 2, 4, and 24 hours after loading dose

• Change in Hemoglobin Levels (g/dL)

  At baseline and at 24 hours post-PCI

• A Change in Hematocrit Levels

  At baseline and at 24 hours post-PCI

• Heparin Dose, Unit/Kg

  24 hours after the PCI

Study Arms (2)

Ticagrelor

ACTIVE COMPARATOR

crushed ticagrelor (180 mg); (n=50 patients)

Drug: Ticagrelor

Eptifibatide bolus+clopidogrel

ACTIVE COMPARATOR

Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients)

Drug: Eptifibatide; Drug: Clopidogrel

Interventions

Ticagrelor DRUG

After randomization, a blood sample will be obtained at baseline for platelet function study, the study drugs, crushed ticagrelor will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests.

Also known as: Brilinta

Ticagrelor

Eptifibatide DRUG

After randomization, a blood sample will be obtained at baseline for platelet function test, the study drugs, clopidogrel and eptifibatide bolus will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests.

Also known as: Integrilin

Eptifibatide bolus+clopidogrel

Clopidogrel DRUG

Also known as: Plavix

Eptifibatide bolus+clopidogrel

Eligibility Criteria

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

You may qualify if:

• Patients with unstable angina/troponin negative ACS.

You may not qualify if:

• need for oral anticoagulation therapy (Warfarin, Dabigatran, Rivaroxaban, Apixaban, Edoxaban)
• increased risk of bradycardia, and the associated therapy with a strong cytochrome P-450 inhibitors (anti-retroviral agents, antifungal agents and some antibiotics eg. Indinavir, Nelfinavir, Lopinavir, Ritonavir, Itraconazole, Ketoconazole, Voriconazole, Clarithromycin, Telithormycin)
• surgery\<4 weeks
• use of any thienopyridines (Clopidogrel, Prasugrel) 7 days prior to randomization
• administration of GP IIb/IIIa inhibitors
• bleeding diathesis or major bleeding episode within 2 weeks
• thrombocytopenia (Platelet count \< 100000)
• incessant chest pain
• hemodynamic instability (Mean arterial pressure \< 65 mm Hg; need for vasopressor or inotropic agents; need for mechanical circulatory support for coronary intervention), NSTEMI as evidenced by elevation of troponin levels (Troponin \> 0.034 ng/ml); renal failure with a serum creatinine \>2.0 mg/dL
• anemia with HCT\<30%.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• Marian MJ, Abu Daya H, Chatterjee A, Al Solaiman F, Sasse MF, Fonbah WS, Workman RW, Johnson BE, Carlson SE, Brott BC, Prabhu SD, Leesar MA. Effects of Crushed Ticagrelor Versus Eptifibatide Bolus Plus Clopidogrel in Troponin-Negative Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention: A Randomized Clinical Trial. J Am Heart Assoc. 2019 Dec 3;8(23):e012844. doi: 10.1161/JAHA.119.012844. Epub 2019 Nov 26.

  PMID: 31766977 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Angina, Unstable

Interventions

Ticagrelor; Eptifibatide; Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Peptides, Cyclic; Peptides; Amino Acids, Peptides, and Proteins; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Leah Pogwizd
• Organization: University of Alabama at Birmingham

leahpogwizd@uabmc.edu

(205) 996-4410

Study Officials

• Massoud Leesar, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: October 6, 2016
• Study Start: November 1, 2016
• Primary Completion: January 30, 2018
• Study Completion: December 1, 2018
• Last Updated: May 4, 2020
• Results First Posted: May 4, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)