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: May 27, 2015
Last verified: May 2015

May 6, 2013
May 27, 2015
June 2013
July 2013   (final data collection date for primary outcome measure)
  • Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) [ Time Frame: Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures. ] [ Designated as safety issue: No ]
    A reference point for the effect of prasugrel alone was chosen for comparison and designated the final draw on study Day 1 (3.5 or 4.0 hours after cangrelor had been discontinued) as the reference for the effect of prasugrel. The extent of aggregation in the presence or absence of the study drugs was examined for each of the endpoints using light transmittance aggregometry (LTA) and expressed as % aggregation in response to 20 micromolar (μM) adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response).
  • Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone [ Time Frame: Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion ] [ Designated as safety issue: No ]
    A reference point for the inhibitory effect of cangrelor alone was chosen for comparison and designated the first draw during the cangrelor infusion (1.0 or 1.5 hours) or within 5 minutes post cangrelor infusion on Day 1. The extent of aggregation was observed during the cangrelor infusion on Day 8, either 24 or 48 hours after discontinuation of prasugrel using light transmittance aggregometry (LTA) and expressed as % aggregation in response to 20 μM adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response).
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
  • Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) [ Time Frame: Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures. ] [ Designated as safety issue: No ]
    A reference point for the effect of prasugrel alone was chosen for comparison and designated the final draw on study Day 1 (3.5 or 4.0 hours after cangrelor had been discontinued) as the reference for the effect of prasugrel. The extent of aggregation in the presence of absence of the study drugs was examined for each of the endpoints as assessed by platelet reaction units (PRU) from the VerifyNow P2Y12 assay.
  • Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone [ Time Frame: Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion ] [ Designated as safety issue: No ]
    A reference point for the inhibitory effect of cangrelor alone was chosen for comparison and designated the first draw during the cangrelor infusion (1.0 or 1.5 hours) or within 5 minutes post cangrelor infusion on Day 1. The extent of aggregation was observed during the cangrelor infusion on Day 8, either 24 or 48 hours after discontinuation of prasugrel as assessed by platelet reaction units (PRU) from the VerifyNow P2Y12 assay.
  • Bleeding Events in Accordance With the GUSTO Scale [ Time Frame: Day 1 through Day 8 ] [ Designated as safety issue: Yes ]
    Bleeding was assessed by history, physical exam, and complete blood count (CBC) that was performed on study Days 1 and 8. Reports of bleeding were to be evaluated by performance of a CBC. Bleeding was to be reported as recommended and quantified in accordance with the GUSTO criteria [The GUSTO Investigators, 1993].
  • 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 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

    Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.

    Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.

  • Experimental: Day 1 - Cangrelor + Prasugrel (60mg) post infusion
    Cangrelor IV + Oral prasugrel (60mg) administered within 5 minutes after cangrelor IV discontinuation
    Interventions:
    • Drug: Cangrelor
    • Drug: Prasugrel
  • Experimental: Day 8 - Prasugrel (10mg) Dosing (5 doses)
    Prasugrel discontinued 48h (n=6) prior to initiation of cangrelor infusion (2h)
    Interventions:
    • Drug: Cangrelor
    • Drug: Prasugrel
  • Experimental: Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h
    Cangrelor IV + oral prasugrel (60mg) administered at 1.5h after the cangrelor infusion start time.
    Interventions:
    • Drug: Cangrelor
    • Drug: Prasugrel
  • Experimental: Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h
    Cangrelor IV + oral prasugrel (60mg) administered at 1.0h after the cangrelor infusion start time.
    Interventions:
    • Drug: Cangrelor
    • Drug: Prasugrel
  • Experimental: Day 8 - Prasugrel (10mg) Dosing (6 doses)
    Prasugrel discontinued 24h 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 percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG).

      AND

    3. Treatment with aspirin (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 University of Vermont Medical Center
The Medicines Company
May 2015

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