Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01979445 | Cangrelor to Clopidogrel or Prasugrel Transition Study | PHASE2 | COMPLETED | 15 | — | — | Dec 2, 2013 | Jan 20, 2014 | Feb 26, 2020 | 1 | United States |
A reference point for prasugrel or clopidogrel was chosen for comparison and designated at 6 or 5.5 hrs after the administration of prasugrel or clopidogrel as the reference for the effect of the oral drug. Platelet function was assessed using light transmittance aggregometry (LTA). LTA measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was expressed as % aggregation in response to 20 micromolar (μM) adenosine diphosphate (ADP) at 300 seconds (sec) (final/terminal aggregation response).
A reference point for cangrelor was chosen for comparison and designated as the administration time of prasugrel 60 mg or clopidogrel 600 mg (2.5, 2, 1.5, or 1 hrs). Platelet function was assessed using LTA. LTA measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was examined using LTA and expressed as % aggregation in response to 20 μM ADP at 300 sec (final/terminal aggregation response).
| Arm | Type | Description |
|---|---|---|
| Prasugrel 30 Min After Cangrelor | EXPERIMENTAL | Prasugrel 60 milligram (mg) administered orally 30 min after the discontinuation of cangrelor infusion on Day 1 (2.5 hours \[hrs\] after initiation of cangrelor infusion). |
| Clopidogrel Within 5 Min After Cangrelor | EXPERIMENTAL | Clopidogrel 600 mg administered orally within 5 min after the discontinuation of the cangrelor infusion on Day 1 (2 hrs after initiation of cangrelor infusion). |
| Clopidogrel 1.5 Hrs During Cangrelor | EXPERIMENTAL | Clopidogrel 600 mg administered orally 1.5 hrs after the initiation of cangrelor infusion on Day 1. |
| Clopidogrel 1 Hr During Cangrelor | EXPERIMENTAL | Clopidogrel 600 mg administered orally 1 hr after the initiation of cangrelor infusion on Day 1. |
| Name | Type | Description |
|---|---|---|
| Cangrelor | DRUG | Cangrelor intravenously (IV) administered as a 30 microgram (µg)/kilogram (kg) bolus, followed by 4 µg/kg/min infusion for 2 hrs on Day 1. |
| Clopidogrel | DRUG | Clopidogrel 600 mg single oral dose |
| Prasugrel | DRUG | Prasugrel 60 mg single oral dose |
Inclusion Criteria: 1. Greater than or equal to 18 and less than 75 years of age, of either sex, and of any race. 2. Stable CAD defined by the following criteria: 1. Previous myocardial infarction defined by admission to the hospital with elevation of markers of injury or the presence of pathol...