Phase 4 N=20 Randomized Quadruple-blind Treatment

PD and PK Profiles of Switching Between Cangrelor and Ticagrelor Following Ticagrelor Pre-treatment

Coronary Artery Disease

Bottom Line

View on ClinicalTrials.gov: NCT04634162 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2023

Primary outcome: Primary: Platelet Reactivity Measured by VerifyNow — 16.9; 12.6 P2Y12 reaction units

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Cangrelor (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: Aug 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Platelet Reactivity Measured by VerifyNow	16.9; 12.6	—

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 ticagrelor is commonly utilized, there is very limited data on the optimal approach for switching between these therapies. The methodological approach for this assessment should rely on comprehensive pharmacodynamics (PD) investigations aimed to assess levels of P2Y12 receptor inhibition, pharmacokinetic (PK) investigations to assess systemic levels of the drug/drug metabolite, and mechanistic investigations by assessment of levels of P2Y12 receptor gene expression. The overarching aim of this investigation is to rule out a drug-drug interaction when ticagrelor is administered prior to cangrelor infusion.

Eligibility Criteria

Inclusion criteria

Patients with known coronary artery disease (defined as prior type I myocardial infarction, coronary revascularization, percutaneous or surgical, or presence of at least a 50% stenosis in any major epicardial vessel).
Age > 18 years old
On aspirin 81mg/qd for at least 1 month

Exclusion criteria

Inability to provide written informed consent
Hemodynamic instability
On treatment with a P2Y12 receptor antagonist (ticlopidine, clopidogrel, prasugrel, ticagrelor) in past 30 days
Known allergies to ticagrelor or cangrelor
Considered at high risk for bleeding
History of intracranial bleeding/hemorrhagic stroke
On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban, apixaban, edoxoban) within past 30 days
Known platelet count <80x106/mL
Known hemoglobin <10 g/dL
Active bleeding
Known end stage renal disease on hemodialysis
Known severe hepatic dysfunction
Acute or severe bronchial asthma or upper airway obstruction.
Patients with sick sinus syndrome (SSS) or high degree AV block without pacemaker protection.
Current treatment with drugs interfering with CYP3A4 metabolism (to avoid interaction with ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromizycin.
Pregnant females [women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study]

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04634162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.