Cangrelor Ticagrelor Transition Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Medicines Company
ClinicalTrials.gov Identifier:
NCT01766466
First received: January 7, 2013
Last updated: April 18, 2014
Last verified: April 2014
  Purpose

To demonstrate that patients treated with cangrelor can be directly switched to oral ticagrelor and that patients treated with ticagrelor 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: Ticagrelor
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: A Study of the Transition From Cangrelor to Ticagrelor, and Ticagrelor 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 of Preservation of Inhibitory Effect Compared With Effect Observed With Cangrelor Alone (at Timepoint 1, Either at 0.5 Hours or 1.25 Hours) or Ticagrelor Alone (Measured 5.25 Hours After Initiation of Cangrelor on Day 1) [ Time Frame: Day 1 measures taken at 2 timepoints after cangrelor infusion start: 0.5 or 1.5 hrs (Timepoint 1) and 5.25 hrs (TImepoint 2) ] [ Designated as safety issue: No ]
    A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor and designated the final draw on study Day 1 (5.25 hours, or 3.25 hours after cangrelor had been discontinued) as the reference for the effect of ticagrelor. Residual platelet reactivity (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry. Residual platelet reactivity (PR) was measured in response to 20 µmol adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response).

  • Extent of Preservation of Inhibitory Effect Compared With Effect Observed During Cangrelor Treatment After Ticagrelor [ Time Frame: Day 5 at 1.0 and 2.0 hours after the initiation of cangrelor infusion ] [ Designated as safety issue: No ]

    A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor.

    Residual platelet reactivity (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). Residual platelet reactivity (PR) was measured in response to 20 µmol ADP at 300 seconds (final/terminal aggregation response).


  • Extent of Aggregation Response During Ticagrelor Treatment [ Time Frame: Day 1 at 2.25, 2.5, 2.75, 3 and 4 hrs following initiation of cangrelor infusion ] [ Designated as safety issue: No ]

    Blood samples were taken for platelet function studies to conduct pharmacodynamic assessments including LTA.

    A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor and designated the final draw on study Day 1 (5.25 hours, or 3.25 hours after cangrelor had been discontinued) as the reference for the effect of ticagrelor.

    Residual platelet reactivity (PR) (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry. Residual platelet reactivity was measured in response to 20 µmol ADP at 300 seconds (final/terminal aggregation response).



Enrollment: 12
Study Start Date: January 2013
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cangrelor IV + Ticagrelor 180mg at 0.5 hr
On Day 1: Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. Ticagrelor (180 mg) was administered at 0.5 h after the initiation of cangrelor infusion.
Drug: cangrelor
Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours.
Drug: Ticagrelor

Ticagrelor 180mg dose: administered 0.5 h or 1.5h after the initiation of cangrelor infusion

Ticagrelor 90mg: 6 or 7 doses (depending on study arm) taken every 12 hours post cangrelor infusion.

Other Name: Brilinta
Experimental: Cangrelor IV + Ticagrelor 90mg (7 doses)

On Day 1: Following completion of cangrelor and ticagrelor dosing, patients were discharged and instructed to take 90 mg ticagrelor every 12 hours for 7 doses (12, 24, 36, 48, 60, 72, and 84 h).

On Day 5: 12 h post last ticagrelor dose (90 mg), patients received another open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours.

Drug: cangrelor
Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours.
Drug: Ticagrelor

Ticagrelor 180mg dose: administered 0.5 h or 1.5h after the initiation of cangrelor infusion

Ticagrelor 90mg: 6 or 7 doses (depending on study arm) taken every 12 hours post cangrelor infusion.

Other Name: Brilinta
Experimental: Cangrelor IV + Ticagrelor 180mg at 1.5 hr
On Day 1: Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. Ticagrelor (180 mg) was administered at 1.5 h after the initiation of cangrelor infusion.
Drug: cangrelor
Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours.
Drug: Ticagrelor

Ticagrelor 180mg dose: administered 0.5 h or 1.5h after the initiation of cangrelor infusion

Ticagrelor 90mg: 6 or 7 doses (depending on study arm) taken every 12 hours post cangrelor infusion.

Other Name: Brilinta
Experimental: Cangrelor IV + Ticagrelor 90mg (6 doses)

On Day 1: Following completion of cangrelor and ticagrelor dosing, patients were discharged and instructed to take 90 mg ticagrelor every 12 hours for 6 doses (12, 24, 36, 48, 60, and 72 h).

On Day 5: 24 h post last ticagrelor dose (90 mg), patients received another open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours.

Drug: cangrelor
Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours.
Drug: Ticagrelor

Ticagrelor 180mg dose: administered 0.5 h or 1.5h after the initiation of cangrelor infusion

Ticagrelor 90mg: 6 or 7 doses (depending on study arm) taken every 12 hours post cangrelor infusion.

Other Name: Brilinta

  Eligibility

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

Inclusion Criteria:

  • greater than / equal to 18 and less than 75 years of age

    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) surgery.

      AND

    3. Treatment with aspirin (ASA) 81 mg daily.

      Exclusion Criteria:

  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: NCT01766466

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, MD Fletcher Allen Health Care
  More Information

No publications provided

Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT01766466     History of Changes
Other Study ID Numbers: MDCO-CAN-12-03
Study First Received: January 7, 2013
Results First Received: April 23, 2013
Last Updated: April 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cangrelor
Ticagrelor
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 July 29, 2014