Pharmacodynamic and Pharmacokinetic of Switching From Cangrelor to Prasugrel in ACS Patients Undergoing PCI

NCT04668144 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: SMF-02
• Study Type: interventional
• Target: 359
• Locations: 1 country
• Sites: 1

Brief Summary

Cangrelor is an intravenous P2Y12 inhibitor utilized as a bridge to achieve adequate platelet inhibition until oral P2Y12 inhibitors achieve their full antiplatelet effects in patients undergoing coronary stenting. Although in this setting the potent oral P2Y12 inhibitor prasugrel is commonly utilized, there is very limited data on the optimal approach for switching between these therapies. The overarching aim of this investigation is to rule out a drug drug interaction (DDI) when cangrelor and prasugrel are concomitantly administered in patients undergoing coronary stenting.

Conditions

Coronary Artery Disease; Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• Platelet Reactivity Measured by VerifyNow

  The primary end point of the study will be the non-inferiority in P2Y12 reaction units (PRU) of cangrelor plus prasugrel concomitantly administered at the start of PCI versus prasugrel only administered at the start of PCI.

  4 hours

Study Arms (3)

Prasugrel

ACTIVE COMPARATOR

Prasugrel only administered at the start of PCI

Drug: Prasugrel

Prasugrel + Cangrelor

EXPERIMENTAL

Cangrelor plus prasugrel concomitantly administered at the start of PCI

Drug: Cangrelor; Drug: Prasugrel

Cangrelor followed by Prasugrel

ACTIVE COMPARATOR

Cangrelor administered at the start of PCI plus prasugrel administered at the end of the cangrelor infusion

Drug: Cangrelor; Drug: Prasugrel

Interventions

Cangrelor DRUG

Cangrelor will be used at the FDA recommended dose using a 30 μg/kg bolus followed by 4 μg/kg/min infusion. The total infusion will last 2 hours.

Also known as: Kengreal

Cangrelor followed by Prasugrel; Prasugrel + Cangrelor

Prasugrel DRUG

Prasugrel will be used in line with FDA recommendations using a 60mg LD followed by a 10mg daily maintenance dose started 24 hours after LD administration

Also known as: Effient

Cangrelor followed by Prasugrel; Prasugrel; Prasugrel + Cangrelor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with NSTE-ACS (UA or NSTEMI) undergoing PCI. NSTE-ACS will be defined as the presence of cardiac ischemic symptoms with ischemic changes (but not ST-segment elevation) on electrocardiogram with or without a positive troponin. However, normal electrocardiograms will be acceptable if the investigator will consider an ACS presentation likely.
• Age between 18 and 75 years old

You may not qualify if:

• Inability to provide written informed consent
• Age \>75 years
• Weight \<60 Kg
• ST-segment elevation myocardial infarction
• On treatment with a P2Y12 receptor antagonist (ticlopidine, clopidogrel, prasugrel, ticagrelor) in past 7 days
• Known allergies to prasugrel or cangrelor
• Considered at high risk for bleeding
• History of ischemic or hemorrhagic stroke or transient ischemic attack
• On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban, apixaban, edoxoban)
• Planned treatment with glycoprotein IIb/IIIa inhibitors (only bailout use allowed)
• Fibrinolytics within 24 hours
• Known platelet count \<80x106/mL
• Known hemoglobin \<10 g/dL
• Active bleeding
• Known end stage renal disease on hemodialysis

Sponsors & Collaborators

• University of Florida: lead
• Scott R. MacKenzie Foundation: collaborator

Study Sites (1)

University of Florida Jacksonville

Jacksonville, Florida, 32209, United States

Location

Related Publications (1)

• Franchi F, Rollini F, Ortega-Paz L, Been L, Giordano S, Galli M, Ghanem G, Garabedian H, Al Saleh T, Uzunoglu E, Rivas A, Pineda AM, Suryadevara S, Soffer D, Zenni MM, Mahowald M, Reiter B, Jilma B, Angiolillo DJ. Switching From Cangrelor to Prasugrel in Patients Undergoing Percutaneous Coronary Intervention: The Switching Antiplatelet-6 (SWAP-6) Study. JACC Cardiovasc Interv. 2023 Oct 23;16(20):2528-2539. doi: 10.1016/j.jcin.2023.08.009. Epub 2023 Aug 21.

  PMID: 37609698 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome

Interventions

cangrelor; Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Francesco Franchi, MD
• Organization: University of Florida College of Medicine Jacksonville

francesco.franchi@jax.ufl.edu

904244206

Study Officials

• Francesco Franchi, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Laboratory personnel will be blinded to treatment assignments
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 16, 2020
• Study Start: February 18, 2021
• Primary Completion: February 2, 2023
• Study Completion: May 11, 2023
• Last Updated: March 20, 2024
• Results First Posted: March 20, 2024

Record last verified: 2024-03

Locations

US (1)