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 AlonePrimary· 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)
Group
Value
95% CI
Prasugrel 30 Min After Cangrelor
1.3
± 1.5
Clopidogrel Within 5 Min After Cangrelor
21.7
± 16.4
Clopidogrel 1.5 Hrs During Cangrelor
50.0
± 16.8
Clopidogrel 1 Hr During Cangrelor
50.3
± 15.9
2.25 hrs
Group
Value
95% CI
Prasugrel 30 Min After Cangrelor
16.3
± 10.1
Clopidogrel Within 5 Min After Cangrelor
26.0
± 7.9
Clopidogrel 1.5 Hrs During Cangrelor
22.2
± 16.0
Clopidogrel 1 Hr During Cangrelor
33.3
± 7.5
2.5 hrs
Group
Value
95% CI
Prasugrel 30 Min After Cangrelor
60.0
± 7.5
Clopidogrel Within 5 Min After Cangrelor
49.7
± 7.1
Clopidogrel 1.5 Hrs During Cangrelor
54.3
± 11.7
Clopidogrel 1 Hr During Cangrelor
62.0
± 3.6
2.75 hrs
Group
Value
95% CI
Prasugrel 30 Min After Cangrelor
63.3
± 1.5
Clopidogrel Within 5 Min After Cangrelor
58.3
± 7.4
Clopidogrel 1.5 Hrs During Cangrelor
56.8
± 11.3
Clopidogrel 1 Hr During Cangrelor
67.7
± 1.2
3 hrs
Group
Value
95% CI
Prasugrel 30 Min After Cangrelor
65.0
± 2.0
Clopidogrel Within 5 Min After Cangrelor
56.0
± 8.9
Clopidogrel 1.5 Hrs During Cangrelor
56.2
± 16.4
Clopidogrel 1 Hr During Cangrelor
65.0
± 9.5
4 hrs
Group
Value
95% CI
Prasugrel 30 Min After Cangrelor
16.3
± 27.4
Clopidogrel Within 5 Min After Cangrelor
38.0
± 31.7
Clopidogrel 1.5 Hrs During Cangrelor
51.2
± 27.4
Clopidogrel 1 Hr During Cangrelor
62.7
± 8.5
5.5 hrs
Group
Value
95% CI
Prasugrel 30 Min After Cangrelor
1.3
± 1.5
Clopidogrel Within 5 Min After Cangrelor
26.7
± 20.5
Clopidogrel 1.5 Hrs During Cangrelor
NA
± NA
Clopidogrel 1 Hr During Cangrelor
NA
± NA
Extent Of Preservation Of Platelet Inhibitory Effect Of Cangrelor Treatment After Prasugrel Or Clopidogrel Compared To Treatment With Cangrelor AlonePrimary· 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)
Group
Value
95% CI
Prasugrel 30 Min After Cangrelor
60.0
± 7.5
Clopidogrel Within 5 Min After Cangrelor
0
± 0
Clopidogrel 1.5 Hrs During Cangrelor
2.0
± 3.5
Clopidogrel 1 Hr During Cangrelor
3.0
± 2.0
1.75 hrs
Group
Value
95% CI
Prasugrel 30 Min After Cangrelor
0.3
± 0.6
Clopidogrel Within 5 Min After Cangrelor
1.0
± 1.0
Clopidogrel 1.5 Hrs During Cangrelor
1.8
± 2.5
Clopidogrel 1 Hr During Cangrelor
1.3
± 0.6
2 hrs
Group
Value
95% CI
Prasugrel 30 Min After Cangrelor
0.3
± 0.6
Clopidogrel Within 5 Min After Cangrelor
NA
± NA
Clopidogrel 1.5 Hrs During Cangrelor
1.5
± 2.0
Clopidogrel 1 Hr During Cangrelor
2.3
± 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 AssaySecondary· 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)
Group
Value
95% CI
Prasugrel 30 Min After Cangrelor
8.0
± 8.7
Clopidogrel Within 5 Min Post Cangrelor
159.0
± 72.7
Clopidogrel 1.5 Hrs During Cangrelor
211.3
± 66.8
Clopidogrel 1 Hr During Cangrelor
197.3
± 15.0
2.25 hrs
Group
Value
95% CI
Prasugrel 30 Min After Cangrelor
76.7
± 23.7
Clopidogrel Within 5 Min Post Cangrelor
99.0
± 27.6
Clopidogrel 1.5 Hrs During Cangrelor
90.3
± 32.3
Clopidogrel 1 Hr During Cangrelor
98.7
± 19.6
2.5 hrs
Group
Value
95% CI
Prasugrel 30 Min After Cangrelor
208.0
± 30.2
Clopidogrel Within 5 Min Post Cangrelor
220.7
± 11.6
Clopidogrel 1.5 Hrs During Cangrelor
229.8
± 24.6
Clopidogrel 1 Hr During Cangrelor
206.3
± 26.9
2.75 hrs
Group
Value
95% CI
Prasugrel 30 Min After Cangrelor
225.7
± 42.5
Clopidogrel Within 5 Min Post Cangrelor
233.0
± 21.7
Clopidogrel 1.5 Hrs During Cangrelor
255.8
± 43.7
Clopidogrel 1 Hr During Cangrelor
214.3
± 11.9
3 hrs
Group
Value
95% CI
Prasugrel 30 Min After Cangrelor
226.0
± 28.5
Clopidogrel Within 5 Min Post Cangrelor
215.7
± 35.0
Clopidogrel 1.5 Hrs During Cangrelor
234.5
± 34.2
Clopidogrel 1 Hr During Cangrelor
212.7
± 10.3
4 hrs
Group
Value
95% CI
Prasugrel 30 Min After Cangrelor
77.0
± 126.5
Clopidogrel Within 5 Min Post Cangrelor
182.0
± 82.3
Clopidogrel 1.5 Hrs During Cangrelor
215.5
± 67.4
Clopidogrel 1 Hr During Cangrelor
203.7
± 11.2
5.5 hrs
Group
Value
95% CI
Prasugrel 30 Min After Cangrelor
24.5
± 34.6
Clopidogrel Within 5 Min Post Cangrelor
155.0
± 69.8
Clopidogrel 1.5 Hrs During Cangrelor
NA
± NA
Clopidogrel 1 Hr During Cangrelor
NA
± 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 AssaySecondary· 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)
Group
Value
95% CI
Prasugrel 30 Min After Cangrelor
208.0
± 30.2
Clopidogrel Within 5 Min After Cangrelor
7.3
± 5.1
Clopidogrel 1.5 Hrs During Cangrelor
17.7
± 18.2
Clopidogrel 1 Hr During Cangrelor
7.0
± 2.0
1.75 hrs
Group
Value
95% CI
Prasugrel 30 Min After Cangrelor
3.3
± 2.3
Clopidogrel Within 5 Min After Cangrelor
3.7
± 2.1
Clopidogrel 1.5 Hrs During Cangrelor
25.0
± 30.5
Clopidogrel 1 Hr During Cangrelor
6.3
± 1.5
2 hrs
Group
Value
95% CI
Prasugrel 30 Min After Cangrelor
5.3
± 2.1
Clopidogrel Within 5 Min After Cangrelor
NA
± NA
Clopidogrel 1.5 Hrs During Cangrelor
28.8
± 18.2
Clopidogrel 1 Hr During Cangrelor
5.7
± 2.1
Bleeding Events In Accordance With GUSTO ScaleSecondary· 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
Group
Value
95% CI
Prasugrel 30 Min After Cangrelor
0
Clopidogrel Within 5 Min After Cangrelor
0
Clopidogrel 1.5 Hrs During Cangrelor
0
Clopidogrel 1 Hr During Cangrelor
0
Moderate
Group
Value
95% CI
Prasugrel 30 Min After Cangrelor
0
Clopidogrel Within 5 Min After Cangrelor
0
Clopidogrel 1.5 Hrs During Cangrelor
0
Clopidogrel 1 Hr During Cangrelor
0
Life-threatening/Severe
Group
Value
95% CI
Prasugrel 30 Min After Cangrelor
0
Clopidogrel Within 5 Min After Cangrelor
0
Clopidogrel 1.5 Hrs During Cangrelor
0
Clopidogrel 1 Hr During Cangrelor
0
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.
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Sponsor: as reported to ClinicalTrials.gov by The Medicines Company
Last refreshed: 26 February 2020
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.