Cangrelor Ticagrelor Transition Study

NCT ID: NCT01766466

Last Updated: 2014-05-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

cangrelor

Intervention Type DRUG

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

Ticagrelor

Intervention Type 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.

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.

Group Type EXPERIMENTAL

cangrelor

Intervention Type DRUG

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

Ticagrelor

Intervention Type 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.

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.

Group Type EXPERIMENTAL

cangrelor

Intervention Type DRUG

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

Ticagrelor

Intervention Type 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.

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.

Group Type EXPERIMENTAL

cangrelor

Intervention Type DRUG

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

Ticagrelor

Intervention Type 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.

Interventions

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cangrelor

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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Brilinta

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Medicines Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David J. Schneider, MD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont Medical Center

Locations

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Fletcher Allen Health Care

Burlington, Vermont, United States

Site Status

Countries

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United States

Other Identifiers

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MDCO-CAN-12-03

Identifier Type: -

Identifier Source: org_study_id

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