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Trial record 7 of 27 for:    cangrelor

Cangrelor to Clopidogrel or Prasugrel Transition Study

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ClinicalTrials.gov Identifier: NCT01979445
Recruitment Status : Completed
First Posted : November 8, 2013
Results First Posted : March 5, 2018
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
The Medicines Company

Brief Summary:

There are two separate objectives in this study:

  1. To demonstrate the pharmacodynamic (PD) profile when participants treated with cangrelor are switched to oral prasugrel 60 mg administered 30 minutes (min) after cangrelor infusion is discontinued
  2. To demonstrate the PD profile when participants treated with cangrelor are switched to oral clopidogrel 600 mg administered during or immediately after cangrelor infusion.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease (CAD) Drug: Cangrelor Drug: Clopidogrel Drug: Prasugrel Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Study of the Transition From Cangrelor to Clopidogrel or Prasugrel in Patients With Coronary Artery Disease.
Actual Study Start Date : December 2, 2013
Actual Primary Completion Date : January 20, 2014
Actual Study Completion Date : January 20, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prasugrel 30 Min After Cangrelor
Prasugrel 60 milligram (mg) administered orally 30 min after the discontinuation of cangrelor infusion on Day 1 (2.5 hours [hrs] after initiation of cangrelor infusion).
Drug: Cangrelor
Cangrelor intravenously (IV) administered as a 30 microgram (µg)/kilogram (kg) bolus, followed by 4 µg/kg/min infusion for 2 hrs on Day 1.

Drug: Prasugrel
Prasugrel 60 mg single oral dose

Experimental: Clopidogrel Within 5 Min After Cangrelor
Clopidogrel 600 mg administered orally within 5 min after the discontinuation of the cangrelor infusion on Day 1 (2 hrs after initiation of cangrelor infusion).
Drug: Cangrelor
Cangrelor intravenously (IV) administered as a 30 microgram (µg)/kilogram (kg) bolus, followed by 4 µg/kg/min infusion for 2 hrs on Day 1.

Drug: Clopidogrel
Clopidogrel 600 mg single oral dose

Experimental: Clopidogrel 1.5 Hrs During Cangrelor
Clopidogrel 600 mg administered orally 1.5 hrs after the initiation of cangrelor infusion on Day 1.
Drug: Cangrelor
Cangrelor intravenously (IV) administered as a 30 microgram (µg)/kilogram (kg) bolus, followed by 4 µg/kg/min infusion for 2 hrs on Day 1.

Drug: Clopidogrel
Clopidogrel 600 mg single oral dose

Experimental: Clopidogrel 1 Hr During Cangrelor
Clopidogrel 600 mg administered orally 1 hr after the initiation of cangrelor infusion on Day 1.
Drug: Cangrelor
Cangrelor intravenously (IV) administered as a 30 microgram (µg)/kilogram (kg) bolus, followed by 4 µg/kg/min infusion for 2 hrs on Day 1.

Drug: Clopidogrel
Clopidogrel 600 mg single oral dose




Primary Outcome Measures :
  1. Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor To Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone [ Time Frame: Day 1 at 5.5 or 6 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 2.25, 2.5, 2.75, 3, 4, and 5.5 hrs after initiation of cangrelor infusion ]
    A reference point for prasugrel or clopidogrel was chosen for comparison and designated at 6 or 5.5 hrs after the administration of prasugrel or clopidogrel as the reference for the effect of the oral drug. Platelet function was assessed using light transmittance aggregometry (LTA). LTA measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was expressed as % aggregation in response to 20 micromolar (μM) adenosine diphosphate (ADP) at 300 seconds (sec) (final/terminal aggregation response).

  2. Extent Of Preservation Of Platelet Inhibitory Effect Of Cangrelor Treatment After Prasugrel Or Clopidogrel Compared To Treatment With Cangrelor Alone [ Time Frame: Day 1 at 1, 1.5, 2, or 2.5 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 1.75 and 2 hrs after initiation of cangrelor infusion ]
    A reference point for cangrelor was chosen for comparison and designated as the administration time of prasugrel 60 mg or clopidogrel 600 mg (2.5, 2, 1.5, or 1 hrs). Platelet function was assessed using LTA. LTA measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was examined using LTA and expressed as % aggregation in response to 20 μM ADP at 300 sec (final/terminal aggregation response).


Secondary Outcome Measures :
  1. Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor to Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone Determined By VerifyNow P2Y12 Assay [ Time Frame: Day 1 at 5.5 or 6 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 2.25, 2.5, 2.75, 3, 4, and 5.5 hrs after initiation of cangrelor infusion ]
    A reference point for prasugrel or clopidogrel was chosen for comparison and designated at 6 or 5.5 hrs after the administration of prasugrel or clopidogrel as the reference for the effect of the oral drug. Platelet function was assessed using the VerifyNow P2Y12 assay. The VerifyNow P2Y12 assay measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was assessed by platelet reaction units (PRU), determined by the VerifyNow P2Y12 assay. The VerifyNow P2Y12 assay is designed to directly measure the effects of drugs on the P2Y12 receptor, using prostaglandin E1 in addition to ADP to increase intraplatelet cyclic adenosine monophosphate (cAMP). Platelet reactivity was expressed in PRU.

  2. Extent of Preservation of Platelet Inhibitory Effect of Cangrelor Treatment After Prasugrel or Clopidogrel Compared to Treatment With Cangrelor Alone Determined By VerifyNow P2Y12 Assay [ Time Frame: Day 1 at 1, 1.5, 2, or 2.5 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 1.75 and 2 hrs after initiation of cangrelor infusion ]
    A reference point for cangrelor was chosen for comparison and designated as the administration time of prasugrel 60 mg or clopidogrel 600 mg (2.5, 2, 1.5, or 1 hrs). Platelet function was assessed using the VerifyNow P2Y12 assay. The VerifyNow P2Y12 assay measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was assessed by PRU, determined by the VerifyNow P2Y12 assay. The VerifyNow P2Y12 assay is designed to directly measure the effects of drugs on the P2Y12 receptor, using prostaglandin E1 in addition to ADP to increase intraplatelet cAMP. Platelet reactivity was expressed in PRU.

  3. Bleeding Events In Accordance With GUSTO Scale [ Time Frame: Screening through the follow-up period (5 to 7 days after Day 1) ]

    Bleeding was assessed by history, physical exam, and complete blood count (CBC) that was performed on study Day 1. Reports of bleeding were to be evaluated by performance of a CBC. Participants were assessed for bleeding events in accordance with the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) scale.

    The severity of bleeding events by GUSTO Criteria is defined as the following:

    • Severe/life-threatening: fatal, intracranial hemorrhage, or if hemodynamic compromise results
    • Moderate: transfusion required
    • Mild: no transfusion or hemodynamic compromise

    A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.




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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Greater than or equal to 18 and less than 75 years of age, of either sex, and of any race.
  2. Stable CAD defined by the following criteria:

    1. Previous myocardial infarction defined by admission to the hospital with elevation of markers of injury or the presence of pathologic Q-waves on at least 2 contiguous electrocardiogram (ECG) leads.

      or

    2. Previous revascularization by percutaneous coronary intervention or coronary artery bypass graft, and
    3. Treatment with aspirin 81 mg daily.

Exclusion Criteria:

  1. Known intolerance or contraindication to cangrelor or prasugrel, or any ingredients of the respective formulation.
  2. Any antiplatelet (other than aspirin) or anticoagulant medication within the previous 30 days.
  3. Acute coronary syndrome within the previous 12 months.
  4. History of bleeding diathesis or known coagulopathy such as; impaired hemostasis; known international normalized ratio (INR) >1.5; past or present bleeding disorder (including congenital bleeding disorders, such as, von Willebrand's disease or hemophilia), acquired bleeding disorders, and unexplained clinically significant bleeding disorders; thrombocytopenia (platelet count less than 100,000/microliter [µL]), or history of thrombocytopenia or neutropenia associated with clopidogrel.
  5. Anemia (for example, hematocrit less than 35%).
  6. Prior stroke (any type), prior cerebral arteriovenous malformation or intracranial aneurysm; recent (<1 month) trauma or major surgery (including bypass surgery).
  7. Known or suspected pregnancy, or lactating females.
  8. Known severe renal insufficiency (glomerular filtration rate less than 30 milliliter [mL]/min).
  9. Inability to provide informed consent.
  10. Moderate or severe hepatic impairment as per Investigator's discretion (elevation of liver function tests).
  11. Inability to swallow oral medication at time of randomization.
  12. Any clinically significant disease or condition affecting a major organ system, including but not limited to gastrointestinal, renal, hepatic, endocrinologic, broncho-pulmonary, neurological, or metabolic disease.
  13. Any surgical or medical condition which, in the judgment of the Investigator, might interfere with the pharmacokinetics, distribution, metabolism, or excretion of the study drug (if applicable).
  14. Treatment with other investigational medicinal products or devices within 30 days or 5 half-lives, whichever is longer, prior to the administration of the drug, or planned use of investigational medicinal products or devices.
  15. Participants who, for any reason, are deemed by the Investigator to be inappropriate for this study, including participants who are unable to communicate or to cooperate with the Investigator.
  16. Participant is the Investigator or his/her deputy, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study.
  17. Active pathological bleeding, or a history of transient ischemic attack.

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): NCT01979445


Locations
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United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
The Medicines Company
Investigators
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Principal Investigator: David J. Schneider, MD University of Vermont Medical Center

Publications of Results:
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Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT01979445     History of Changes
Other Study ID Numbers: MDCO-CAN-13-02
First Posted: November 8, 2013    Key Record Dates
Results First Posted: March 5, 2018
Last Update Posted: March 5, 2018
Last Verified: February 2018
Keywords provided by The Medicines Company:
CAD
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
Clopidogrel
Prasugrel Hydrochloride
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