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

May 6, 2013
August 8, 2013
June 2013
July 2013   (final data collection date for primary outcome measure)
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)

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)

Complete list of historical versions of study NCT01852019 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
    Comparisons and time frame as in the primary and Day 8 above, assessed with ADP-induced platelet reactivity units (PRU, VerifyNow® P2Y12 assay)
  • Comparisons and time frame as in the primary and Day 8 above, with ADP-induced platelet activation assessed with the use of flow cytometry. [ 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 ]
Not Provided
Not Provided
 
Cangrelor Prasugrel Transition Study
A Study of the Transition From IV Cangrelor to Oral Prasugrel, and Prasugrel to Cangrelor, in Patients With Coronary Artery Disease.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Coronary Artery Disease
  • 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 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)

    Interventions:
    • Drug: cangrelor
    • Drug: Prasugrel
  • Experimental: Day 8
    Prasugrel discontinued 24h (n=6) or 48h (n=6) prior to initiation of cangrelor infusion (2h)
    Interventions:
    • Drug: cangrelor
    • Drug: Prasugrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
July 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01852019
MDCO-CAN-13-01
No
The Medicines Company
The Medicines Company
Not Provided
Principal Investigator: David J. Schneider Fletcher Allen Health Care
The Medicines Company
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP