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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2 coronary-artery-disease

Timeline

Completed

Started Jun 2013

Shorter than P25 for phase_2 coronary-artery-disease

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1 month study duration

First Submitted

Initial submission to the registry

May 6, 2013

Completed

7 days until next milestone

First Posted

Study publicly available on registry

May 13, 2013

Completed

19 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed

1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed

1.9 years until next milestone

Results Posted

Study results publicly available

May 28, 2015

Completed

Last Updated

June 24, 2015

Status Verified

May 1, 2015

Enrollment Period

1 month

First QC Date

May 6, 2013

Results QC Date

August 1, 2014

Last Update Submit

May 27, 2015

Conditions

Coronary Artery Disease

Keywords

CAD

Outcome Measures

Primary Outcomes (2)

Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)
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).
Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures.
Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone
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).
Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion

Secondary Outcomes (3)

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.
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
Bleeding Events in Accordance With the GUSTO Scale
Day 1 through Day 8

Study Arms (5)

Day 1 - Cangrelor + Prasugrel (60mg) post infusion

EXPERIMENTAL

Cangrelor IV + Oral prasugrel (60mg) administered within 5 minutes after cangrelor IV discontinuation