Cangrelor Ticagrelor Transition Study

A Study of the Transition From Cangrelor to Ticagrelor, and Ticagrelor to Cangrelor in Patients With Coronary Artery Disease

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: cangrelor; Drug: Ticagrelor

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Fletcher Allen Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: 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 Names: Brilinta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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).	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)
Extent of Preservation of Inhibitory Effect Compared With Effect Observed During Cangrelor Treatment After Ticagrelor	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).	Day 5 at 1.0 and 2.0 hours after the initiation of cangrelor infusion
Extent of Aggregation Response During Ticagrelor Treatment	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).	Day 1 at 2.25, 2.5, 2.75, 3 and 4 hrs following initiation of cangrelor infusion

Collaborators and Investigators

• Sponsor: The Medicines Company

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: January 7, 2013
• First Submitted That Met QC Criteria: January 9, 2013
• First Posted (Estimate): January 11, 2013

Study Record Updates

• Last Update Posted (Estimate): May 19, 2014
• Last Update Submitted That Met QC Criteria: April 18, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Ticagrelor; Cangrelor
• Other Study ID Numbers: MDCO-CAN-12-03