Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
12 participants
INTERVENTIONAL
2013-01-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
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.
cangrelor
Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours.
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.
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.
cangrelor
Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours.
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.
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.
cangrelor
Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours.
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.
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.
cangrelor
Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours.
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.
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion 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) surgery.
AND
3. Treatment with aspirin (ASA) 81 mg daily.
18 Years
75 Years
ALL
No
Sponsors
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The Medicines Company
INDUSTRY
Responsible Party
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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
Countries
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Other Identifiers
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MDCO-CAN-12-03
Identifier Type: -
Identifier Source: org_study_id
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