Cangrelor Prasugrel Transition Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Medicines Company
ClinicalTrials.gov Identifier:
NCT01852019
First received: May 6, 2013
Last updated: August 8, 2013
Last verified: May 2013
  Purpose

To demonstrate that patients treated with cangrelor can be directly switched to oral prasugrel and that patients treated with prasugrel can be switched to cangrelor without a significant decrease in the extent of inhibition of platelet aggregation.


Condition Intervention Phase
Coronary Artery Disease
Drug: cangrelor
Drug: Prasugrel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Study of the Transition From IV Cangrelor to Oral Prasugrel, and Prasugrel to Cangrelor, in Patients With Coronary Artery Disease.

Resource links provided by NLM:


Further study details as provided by The Medicines Company:

Primary Outcome Measures:
  • Extent to which inhibitory effect is preserved during the transition period (change over time) compared with the effect observed with cangrelor alone or prasugrel alone. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

    Assessment of effect is with terminal/final light transmission aggregation (LTA) in response to 20 µM ADP.

    Cangrelor alone = (at Timepoint 1, either at 1.5 hours or 2 hours)

    Prasugrel alone = (measured 3 hours after prasugrel dosing on Day 1)



Secondary Outcome Measures:
  • Day 8, change in inhibition from prasugrel alone (first timepoint on Day 1) to cangrelor plus prasugrel (next point.) assessed with final LTA, 20 µM ADP. [ Time Frame: Day 1 and Day 8 ] [ Designated as safety issue: No ]
  • Day 8, change in inhibition from prasugrel alone (first timepoint on Day 1) to cangrelor plus prasugrel (next point.) assessed with VerifyNow PRU. [ Time Frame: Day 1 and Day 8 ] [ Designated as safety issue: No ]
  • Bleeding events in accordance with the GUSTO scale [ Time Frame: Day 8 ] [ Designated as safety issue: Yes ]
  • Day 8, change in inhibition from prasugrel alone (first timepoint on Day 1) to cangrelor plus prasugrel (next point.) assessed with by flow cytometry. [ Time Frame: Day 1 and Day 8 ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: June 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Day 1

Cangrelor IV (2h) + oral prasugrel (60mg) administered within 5 minutes after cangrelor IV discontinuation (n=6)

or

Cangrelor IV (2h) + oral prasugrel (60mg) administered at infusion time 1.5h (n=6)

Drug: cangrelor
Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Drug: Prasugrel
Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.5 hours ±5 minutes, n=6) or within 5 minutes of discontinuing the cangrelor infusion (n=6). Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours.
Experimental: Day 8
Prasugrel discontinued 24h (n=6) or 48h (n=6) prior to initiation of cangrelor infusion (2h)
Drug: cangrelor
Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Drug: Prasugrel
Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.5 hours ±5 minutes, n=6) or within 5 minutes of discontinuing the cangrelor infusion (n=6). Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. greater than / equal to 18 and less than 75 years of age
  2. stable coronary artery disease 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 PCI or CABG. AND
    3. Treatment with ASA 81 mg daily.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01852019

Locations
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
The Medicines Company
Investigators
Principal Investigator: David J. Schneider Fletcher Allen Health Care
  More Information

No publications provided

Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT01852019     History of Changes
Other Study ID Numbers: MDCO-CAN-13-01
Study First Received: May 6, 2013
Last Updated: August 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by The Medicines Company:
CAD

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Prasugrel
Cangrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014