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Trial record 13 of 27 for:    cangrelor

In Vitro Pharmacodynamic Effects of Cangrelor in Ticagrelor Treated Patients

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ClinicalTrials.gov Identifier: NCT02081443
Recruitment Status : Completed
First Posted : March 7, 2014
Results First Posted : March 3, 2017
Last Update Posted : April 4, 2017
Sponsor:
Collaborator:
The Medicines Company
Information provided by (Responsible Party):
University of Florida

Brief Summary:
Cangrelor is a potent intravenous P2Y12 receptor inhibitor with rapid onset and offset of action associated with a greater reduction in ischemic events, including stent thrombosis, in patients undergoing stent procedures who have not been pretreated with clopidogrel. In vitro investigations have shown cangrelor to be associated with more rapid, potent, and consistent platelet inhibition in patients on maintenance prasugrel therapy exposed to a re-loading dose of prasugrel. However, if cangrelor exerts similar effects in ticagrelor treated patients remain unknown. The aim of the present study is to evaluate the effects on platelet function achieved after in vitro incubation with cangrelor in patients on ticagrelor maintenance dose who receive a loading dose of ticagrelor.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Ticagrelor 180mg Drug: Ticagrelor 90mg Not Applicable

Detailed Description:
A higher degree of platelet inhibition remains the goal in the peri-interventional period in patients undergoing percutaneous coronary interventions (PCI) as this is associated with a lower rate of adverse ischemic events. Ticagrelor and prasugrel are novel and potent generation oral P2Y12 receptor inhibitors associated with a greater reduction in ischemic events compared with clopidogrel. However, both prasugrel and ticagrelor have recently showed variability in pharmacodynamic (PD) response, particularly in patients with ST-elevation myocardial infarction (STEMI) undergoing primary PCI, exposing these patients to an increased risk of thrombotic complications. These findings support the need for intravenous agents with more rapid platelet inhibiting effects. Cangrelor is a potent intravenous P2Y12 receptor inhibitor with rapid onset and offset of action associated with a greater reduction in ischemic events, including stent thrombosis, in patients undergoing PCI who have not been pretreated with clopidogrel. In vitro PD investigations have shown cangrelor to be associated with more rapid, potent, and consistent platelet inhibition in patients on maintenance prasugrel therapy exposed to a re-loading dose of prasugrel. However, if cangrelor exerts similar effects in ticagrelor treated patients remain unknown. The aim of the present study is to evaluate the PD effects achieved after in vitro incubation with cangrelor in patients on ticagrelor maintenance dose who receive a loading dose of ticagrelor. The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. PD assessments will be done before and after incubation with cangrelor at 3 time-points. The study hypothesis is that in vitro incubation with cangrelor will lead to incremental P2Y12 receptor blockade, the extent of which will be inversely related to dose of ticagrelor.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: In Vitro Pharmacodynamic Effects of Cangrelor on Platelet P2Y12 Receptor Mediated Signaling in Ticagrelor Treated Patients
Study Start Date : April 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ticagrelor 180mg
The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
Drug: Ticagrelor 90mg
The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
Other Name: Brilinta

Active Comparator: Ticagrelor 90mg
The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
Drug: Ticagrelor 180mg
The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
Other Name: Brilinta




Primary Outcome Measures :
  1. Platelet Reactivity Index (PRI) Determined by Whole Blood Vasodilator-stimulated Phosphoprotein (VASP) [ Time Frame: Baseline ]
    PRI determined by VASP between before and after incubation with 500 nM Cangrelor in each arm of treatment


Secondary Outcome Measures :
  1. PRI Measured by VASP [ Time Frame: 1 hour ]
    PRI determined by VASP between before and after incubation with 500 nM Cangrelor in each arm of treatment

  2. PRI Measured by VASP [ Time Frame: 4 hours ]
    PRI determined by VASP between before and after incubation with 500 nM Cangrelor in each arm of treatment



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Patients with angiographically documented coronary artery disease.
  2. Age between 18 to 80 years
  3. On treatment per standard of care with ticagrelor 90mg/b.i.d. and aspirin <100mg/day for at least 14 days.

Exclusion criteria

  1. History of intracranial bleeding
  2. Known severe hepatic dysfunction
  3. Known hypersensitivy
  4. Active bleeding or propensity to bleed
  5. Platelet count <80x106/mL
  6. Hemodynamic instability
  7. Serum creatinine <30 mL/min
  8. Use of oral anticoagulants (Vitamin K antagonist, dabigatran, rivaroxaban, apixaban)
  9. Recent (<14 days) antiplatelet treatment with a glycoprotein IIb/IIIa inhibitor
  10. Blood dyscrasia
  11. Patients with sick sinus syndrome (SSS) or II or III degree AV block without pacemaker
  12. Drugs interfering CYP3A4 metabolism (to avoid interaction with Ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromicin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir and telithromizycin
  13. Hemoglobin < 10g/dL
  14. Pregnant females [women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study].

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02081443


Locations
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United States, Florida
Dominick Angiolillo
Jacksonville, Florida, United States, 32209
Sponsors and Collaborators
University of Florida
The Medicines Company
Investigators
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Principal Investigator: Dominick Angiolillo University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02081443     History of Changes
Other Study ID Numbers: CIT
First Posted: March 7, 2014    Key Record Dates
Results First Posted: March 3, 2017
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Florida:
coronary artery disease
platelet function
ticagrelor
cangrelor
Additional relevant MeSH terms:
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Cangrelor
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs