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NCT01979445: BRIDGE

Cangrelor to Clopidogrel or Prasugrel Transition Study

Completed Phase 2 Results posted Last updated 26 February 2020
What this trial tests

Phase 2 trial testing Cangrelor in Coronary Artery Disease (CAD) in 15 participants. Completed in 20 January 2014.

Timeline
2 December 2013
Primary endpoint
20 January 2014
20 January 2014

Quick facts

Lead sponsorThe Medicines Company
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposebasic science
Enrollment15
Start date2 December 2013
Primary completion20 January 2014
Estimated completion20 January 2014
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

The Medicines Company — full company profile →

Who can join

Adults 18 to 74, any sex, with Coronary Artery Disease (CAD). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor To Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone Primary · Day 1 at 5.5 or 6 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 2.25, 2.5, 2.75, 3, 4, and 5.5 hrs after initiation of cangrelor infusion

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 re

Prasugrel/Clopidogrel Reference (6 or 5.5 hrs)
GroupValue95% CI
Prasugrel 30 Min After Cangrelor1.3± 1.5
Clopidogrel Within 5 Min After Cangrelor21.7± 16.4
Clopidogrel 1.5 Hrs During Cangrelor50.0± 16.8
Clopidogrel 1 Hr During Cangrelor50.3± 15.9
2.25 hrs
GroupValue95% CI
Prasugrel 30 Min After Cangrelor16.3± 10.1
Clopidogrel Within 5 Min After Cangrelor26.0± 7.9
Clopidogrel 1.5 Hrs During Cangrelor22.2± 16.0
Clopidogrel 1 Hr During Cangrelor33.3± 7.5
2.5 hrs
GroupValue95% CI
Prasugrel 30 Min After Cangrelor60.0± 7.5
Clopidogrel Within 5 Min After Cangrelor49.7± 7.1
Clopidogrel 1.5 Hrs During Cangrelor54.3± 11.7
Clopidogrel 1 Hr During Cangrelor62.0± 3.6
2.75 hrs
GroupValue95% CI
Prasugrel 30 Min After Cangrelor63.3± 1.5
Clopidogrel Within 5 Min After Cangrelor58.3± 7.4
Clopidogrel 1.5 Hrs During Cangrelor56.8± 11.3
Clopidogrel 1 Hr During Cangrelor67.7± 1.2
3 hrs
GroupValue95% CI
Prasugrel 30 Min After Cangrelor65.0± 2.0
Clopidogrel Within 5 Min After Cangrelor56.0± 8.9
Clopidogrel 1.5 Hrs During Cangrelor56.2± 16.4
Clopidogrel 1 Hr During Cangrelor65.0± 9.5
4 hrs
GroupValue95% CI
Prasugrel 30 Min After Cangrelor16.3± 27.4
Clopidogrel Within 5 Min After Cangrelor38.0± 31.7
Clopidogrel 1.5 Hrs During Cangrelor51.2± 27.4
Clopidogrel 1 Hr During Cangrelor62.7± 8.5
5.5 hrs
GroupValue95% CI
Prasugrel 30 Min After Cangrelor1.3± 1.5
Clopidogrel Within 5 Min After Cangrelor26.7± 20.5
Clopidogrel 1.5 Hrs During CangrelorNA± NA
Clopidogrel 1 Hr During CangrelorNA± NA
Extent Of Preservation Of Platelet Inhibitory Effect Of Cangrelor Treatment After Prasugrel Or Clopidogrel Compared To Treatment With Cangrelor Alone Primary · Day 1 at 1, 1.5, 2, or 2.5 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 1.75 and 2 hrs after initiation of cangrelor infusion

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).

Cangrelor Reference (2.5, 2, 1.5, or 1 hrs)
GroupValue95% CI
Prasugrel 30 Min After Cangrelor60.0± 7.5
Clopidogrel Within 5 Min After Cangrelor0± 0
Clopidogrel 1.5 Hrs During Cangrelor2.0± 3.5
Clopidogrel 1 Hr During Cangrelor3.0± 2.0
1.75 hrs
GroupValue95% CI
Prasugrel 30 Min After Cangrelor0.3± 0.6
Clopidogrel Within 5 Min After Cangrelor1.0± 1.0
Clopidogrel 1.5 Hrs During Cangrelor1.8± 2.5
Clopidogrel 1 Hr During Cangrelor1.3± 0.6
2 hrs
GroupValue95% CI
Prasugrel 30 Min After Cangrelor0.3± 0.6
Clopidogrel Within 5 Min After CangrelorNA± NA
Clopidogrel 1.5 Hrs During Cangrelor1.5± 2.0
Clopidogrel 1 Hr During Cangrelor2.3± 1.2
Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor to Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone Determined By VerifyNow P2Y12 Assay Secondary · Day 1 at 5.5 or 6 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 2.25, 2.5, 2.75, 3, 4, and 5.5 hrs after initiation of cangrelor infusion

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 the VerifyNow P2Y12 assay. The VerifyNow P2Y12 assay 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 assessed by platelet reaction units (PRU), determined by the VerifyNow P2Y12 assay. The VerifyNow P2Y12 assay is designed to direct

Prasugrel/Clopidogrel Reference (6 or 5.5 hrs)
GroupValue95% CI
Prasugrel 30 Min After Cangrelor8.0± 8.7
Clopidogrel Within 5 Min Post Cangrelor159.0± 72.7
Clopidogrel 1.5 Hrs During Cangrelor211.3± 66.8
Clopidogrel 1 Hr During Cangrelor197.3± 15.0
2.25 hrs
GroupValue95% CI
Prasugrel 30 Min After Cangrelor76.7± 23.7
Clopidogrel Within 5 Min Post Cangrelor99.0± 27.6
Clopidogrel 1.5 Hrs During Cangrelor90.3± 32.3
Clopidogrel 1 Hr During Cangrelor98.7± 19.6
2.5 hrs
GroupValue95% CI
Prasugrel 30 Min After Cangrelor208.0± 30.2
Clopidogrel Within 5 Min Post Cangrelor220.7± 11.6
Clopidogrel 1.5 Hrs During Cangrelor229.8± 24.6
Clopidogrel 1 Hr During Cangrelor206.3± 26.9
2.75 hrs
GroupValue95% CI
Prasugrel 30 Min After Cangrelor225.7± 42.5
Clopidogrel Within 5 Min Post Cangrelor233.0± 21.7
Clopidogrel 1.5 Hrs During Cangrelor255.8± 43.7
Clopidogrel 1 Hr During Cangrelor214.3± 11.9
3 hrs
GroupValue95% CI
Prasugrel 30 Min After Cangrelor226.0± 28.5
Clopidogrel Within 5 Min Post Cangrelor215.7± 35.0
Clopidogrel 1.5 Hrs During Cangrelor234.5± 34.2
Clopidogrel 1 Hr During Cangrelor212.7± 10.3
4 hrs
GroupValue95% CI
Prasugrel 30 Min After Cangrelor77.0± 126.5
Clopidogrel Within 5 Min Post Cangrelor182.0± 82.3
Clopidogrel 1.5 Hrs During Cangrelor215.5± 67.4
Clopidogrel 1 Hr During Cangrelor203.7± 11.2
5.5 hrs
GroupValue95% CI
Prasugrel 30 Min After Cangrelor24.5± 34.6
Clopidogrel Within 5 Min Post Cangrelor155.0± 69.8
Clopidogrel 1.5 Hrs During CangrelorNA± NA
Clopidogrel 1 Hr During CangrelorNA± NA
Extent of Preservation of Platelet Inhibitory Effect of Cangrelor Treatment After Prasugrel or Clopidogrel Compared to Treatment With Cangrelor Alone Determined By VerifyNow P2Y12 Assay Secondary · Day 1 at 1, 1.5, 2, or 2.5 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 1.75 and 2 hrs after initiation of cangrelor infusion

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 the VerifyNow P2Y12 assay. The VerifyNow P2Y12 assay 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 assessed by PRU, determined by the VerifyNow P2Y12 assay. The VerifyNow P2Y12 assay is designed to directly measure the effects of drugs on the P2Y12 receptor, using prosta

Cangrelor Reference (2.5, 2, 1.5, or 1 hrs)
GroupValue95% CI
Prasugrel 30 Min After Cangrelor208.0± 30.2
Clopidogrel Within 5 Min After Cangrelor7.3± 5.1
Clopidogrel 1.5 Hrs During Cangrelor17.7± 18.2
Clopidogrel 1 Hr During Cangrelor7.0± 2.0
1.75 hrs
GroupValue95% CI
Prasugrel 30 Min After Cangrelor3.3± 2.3
Clopidogrel Within 5 Min After Cangrelor3.7± 2.1
Clopidogrel 1.5 Hrs During Cangrelor25.0± 30.5
Clopidogrel 1 Hr During Cangrelor6.3± 1.5
2 hrs
GroupValue95% CI
Prasugrel 30 Min After Cangrelor5.3± 2.1
Clopidogrel Within 5 Min After CangrelorNA± NA
Clopidogrel 1.5 Hrs During Cangrelor28.8± 18.2
Clopidogrel 1 Hr During Cangrelor5.7± 2.1
Bleeding Events In Accordance With GUSTO Scale Secondary · Screening through the follow-up period (5 to 7 days after Day 1)

Bleeding was assessed by history, physical exam, and complete blood count (CBC) that was performed on study Day 1. Reports of bleeding were to be evaluated by performance of a CBC. Participants were assessed for bleeding events in accordance with the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) scale. The severity of bleeding events by GUSTO Criteria is defined as the following: * Severe/life-threatening: fatal, intracranial hemorrhage, or if hemodynamic compromise results * Moderate: transfusion required * Mild: no transfusion or hemodynamic compromise A summary of s

Mild
GroupValue95% CI
Prasugrel 30 Min After Cangrelor0
Clopidogrel Within 5 Min After Cangrelor0
Clopidogrel 1.5 Hrs During Cangrelor0
Clopidogrel 1 Hr During Cangrelor0
Moderate
GroupValue95% CI
Prasugrel 30 Min After Cangrelor0
Clopidogrel Within 5 Min After Cangrelor0
Clopidogrel 1.5 Hrs During Cangrelor0
Clopidogrel 1 Hr During Cangrelor0
Life-threatening/Severe
GroupValue95% CI
Prasugrel 30 Min After Cangrelor0
Clopidogrel Within 5 Min After Cangrelor0
Clopidogrel 1.5 Hrs During Cangrelor0
Clopidogrel 1 Hr During Cangrelor0

Sponsor's own description

There are two separate objectives in this study: 1. To demonstrate the pharmacodynamic (PD) profile when participants treated with cangrelor are switched to oral prasugrel 60 mg administered 30 minutes (min) after cangrelor infusion is discontinued 2. To demonstrate the PD profile when participants treated with cangrelor are switched to oral clopidogrel 600 mg administered during or immediately after cangrelor infusion.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Cangrelor

Trials testing the same drug.

Other recruiting trials for Coronary Artery Disease (CAD)

Currently open trials in the same condition.

Other The Medicines Company trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01979445.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing