Cangrelor Ticagrelor Transition Study

NCT01766466 | Completed Phase 2 Results

• 1 other identifier: MDCO-CAN-12-03
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

Cangrelor IV + Ticagrelor 180mg at 0.5 hr

EXPERIMENTAL

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; Drug: Ticagrelor

Cangrelor IV + Ticagrelor 90mg (7 doses)

EXPERIMENTAL

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; Drug: Ticagrelor

Cangrelor IV + Ticagrelor 180mg at 1.5 hr

EXPERIMENTAL

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; Drug: Ticagrelor

Cangrelor IV + Ticagrelor 90mg (6 doses)

EXPERIMENTAL

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; Drug: Ticagrelor

Interventions

cangrelor DRUG

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

Cangrelor IV + Ticagrelor 180mg at 0.5 hr; Cangrelor IV + Ticagrelor 180mg at 1.5 hr; Cangrelor IV + Ticagrelor 90mg (6 doses); Cangrelor IV + Ticagrelor 90mg (7 doses)

Ticagrelor DRUG

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.

Also known as: Brilinta

Cangrelor IV + Ticagrelor 180mg at 0.5 hr; Cangrelor IV + Ticagrelor 180mg at 1.5 hr; Cangrelor IV + Ticagrelor 90mg (6 doses); Cangrelor IV + Ticagrelor 90mg (7 doses)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• greater than / equal to 18 and less than 75 years of age
• 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.
• Previous revascularization by percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery.
• AND
• Treatment with aspirin (ASA) 81 mg daily.

Sponsors & Collaborators

• The Medicines Company: lead

Study Sites (1)

Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

cangrelor; Ticagrelor

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Jayne Prats, PhD - VP, Global Knowledge Management
• Organization: The Medicines Company

jayne.prats@themedco.com

888.779.MDCO

Study Officials

• David J. Schneider, MD

  University of Vermont Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: January 11, 2013
• Study Start: January 1, 2013
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: May 19, 2014
• Results First Posted: May 19, 2014

Record last verified: 2014-04

Locations

US (1)