Cangrelor Prasugrel Transition Study

Phase 2

Completed

Conditions: Coronary Artery Disease

Interventions: Drug: Cangrelor
Drug: Prasugrel

Registration Number: NCT01852019

Lead Sponsor: The Medicines Company

Brief Summary: To demonstrate that patients treated with cangrelor can be directly switched to oral prasugrel and that patients treated with prasugrel can be switched to cangrelor without a significant decrease in the extent of inhibition of platelet aggregation.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 12

Inclusion Criteria

greater than / equal to 18 and less than 75 years of age
stable coronary artery disease 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 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).
  
  AND
3. Treatment with aspirin (ASA) 81 mg daily.

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Day 8 - Prasugrel (10mg) Dosing (5 doses)	Cangrelor	Prasugrel discontinued 48h (n=6) prior to initiation of cangrelor infusion (2h)
Day 1 - Cangrelor + Prasugrel (60mg) post infusion	Cangrelor	Cangrelor IV + Oral prasugrel (60mg) administered within 5 minutes after cangrelor IV discontinuation
Day 1 - Cangrelor + Prasugrel (60mg) post infusion	Prasugrel	Cangrelor IV + Oral prasugrel (60mg) administered within 5 minutes after cangrelor IV discontinuation
Day 8 - Prasugrel (10mg) Dosing (5 doses)	Prasugrel	Prasugrel discontinued 48h (n=6) prior to initiation of cangrelor infusion (2h)
Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h	Prasugrel	Cangrelor IV + oral prasugrel (60mg) administered at 1.5h after the cangrelor infusion start time.
Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h	Prasugrel	Cangrelor IV + oral prasugrel (60mg) administered at 1.0h after the cangrelor infusion start time.
Day 8 - Prasugrel (10mg) Dosing (6 doses)	Cangrelor	Prasugrel discontinued 24h prior to initiation of cangrelor infusion (2h)
Day 8 - Prasugrel (10mg) Dosing (6 doses)	Prasugrel	Prasugrel discontinued 24h prior to initiation of cangrelor infusion (2h)
Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h	Cangrelor	Cangrelor IV + oral prasugrel (60mg) administered at 1.5h after the cangrelor infusion start time.
Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h	Cangrelor	Cangrelor IV + oral prasugrel (60mg) administered at 1.0h after the cangrelor infusion start time.

Primary Outcome Measures

Name	Time	Method
Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)	Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures.	A reference point for the effect of prasugrel alone was chosen for comparison and designated the final draw on study Day 1 (3.5 or 4.0 hours after cangrelor had been discontinued) as the reference for the effect of prasugrel. 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) and expressed as % aggregation in response to 20 micromolar (μM) adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response).
Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone	Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion	A reference point for the inhibitory effect of cangrelor alone was chosen for comparison and designated the first draw during the cangrelor infusion (1.0 or 1.5 hours) or within 5 minutes post cangrelor infusion on Day 1. The extent of aggregation was observed during the cangrelor infusion on Day 8, either 24 or 48 hours after discontinuation of prasugrel using light transmittance aggregometry (LTA) and expressed as % aggregation in response to 20 μM adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response).

Secondary Outcome Measures

Name	Time	Method
Bleeding Events in Accordance With the GUSTO Scale	Day 1 through Day 8	Bleeding was assessed by history, physical exam, and complete blood count (CBC) that was performed on study Days 1 and 8. Reports of bleeding were to be evaluated by performance of a CBC. Bleeding was to be reported as recommended and quantified in accordance with the GUSTO criteria \[The GUSTO Investigators, 1993\].
Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)	Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures.	A reference point for the effect of prasugrel alone was chosen for comparison and designated the final draw on study Day 1 (3.5 or 4.0 hours after cangrelor had been discontinued) as the reference for the effect of prasugrel. The extent of aggregation in the presence of absence of the study drugs was examined for each of the endpoints as assessed by platelet reaction units (PRU) from the VerifyNow P2Y12 assay.
Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone	Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion	A reference point for the inhibitory effect of cangrelor alone was chosen for comparison and designated the first draw during the cangrelor infusion (1.0 or 1.5 hours) or within 5 minutes post cangrelor infusion on Day 1. The extent of aggregation was observed during the cangrelor infusion on Day 8, either 24 or 48 hours after discontinuation of prasugrel as assessed by platelet reaction units (PRU) from the VerifyNow P2Y12 assay.