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Trial record 8 of 27 for:    cangrelor

Cangrelor Ticagrelor Transition Study

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ClinicalTrials.gov Identifier: NCT01766466
Recruitment Status : Completed
First Posted : January 11, 2013
Results First Posted : May 19, 2014
Last Update Posted : May 19, 2014
Sponsor:
Information provided by (Responsible Party):
The Medicines Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label)
Condition Coronary Artery Disease
Interventions Drug: cangrelor
Drug: Ticagrelor
Enrollment 12
Recruitment Details The purpose of this study was to study the pharmacodynamic characteristics of transition from IV cangrelor to oral ticagrelor, and ticagrelor to cangrelor in patients with coronary artery disease. This was a single-center study, conducted in Jan-Feb 2013.
Pre-assignment Details Patients with coronary artery disease who were taking aspirin, but not P2Y12 inhibition were enrolled.
Arm/Group Title Day 1 - Cangrelor + Ticagrelor (180mg) at 0.5h Day 5 - Ticagrelor (90 mg) Dosing (6 Doses) Day 1 - Cangrelor + Ticagrelor (180mg) at 1.5h Day 5 - Ticagrelor (90mg) Dosing (7 Doses)
Hide Arm/Group Description Cangrelor IV (2h) + oral ticagrelor (180mg) administered at 0.5h after the initiation of the cangrelor infusion. Ticagrelor (90mg) discontinued 24h prior to the initiation of a 2h cangrelor infusion. Cangrelor IV (2h) + oral ticagrelor (180mg) administered at 1.5h after the initiation of the cangrelor infusion. Ticagrelor (90mg) discontinued 12h prior to the initiation of a 2h cangrelor infusion.
Period Title: Day 1
Started 6 0 6 0
Completed 6 0 6 0
Not Completed 0 0 0 0
Period Title: Day 5
Started 0 6 0 6
Completed 0 6 0 6
Not Completed 0 0 0 0
Arm/Group Title ITT Population - Ticagrelor 6 Doses ITT Population - Ticagrelor 7 Doses Total
Hide Arm/Group Description

On Day 1: Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. Ticagrelor (180 mg) was administered at 0.5 h or 1.5 h after the initiation of cangrelor infusion. Patients were discharged and instructed to take 90 mg ticagrelor every 12 hours for 6 doses.

On Day 5: Cangrelor was administered after ticagrelor (90 mg)was discontinued 24 hours prior.

On Day 1: Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. Ticagrelor (180 mg) was administered at 0.5 h or 1.5 h after the initiation of cangrelor infusion. Patients were discharged and instructed to take 90 mg ticagrelor every 12 hours for 7 doses.

On Day 5: Cangrelor was administered after ticagrelor (90 mg)was discontinued 12 hours prior.

Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
66.3  (7.17) 66.5  (4.32) 66.4  (5.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
6
 100.0%
6
 100.0%
12
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 12 participants
6 6 12
1.Primary Outcome
Title Extent of Preservation of Inhibitory Effect Compared With Effect Observed With Cangrelor Alone (at Timepoint 1, Either at 0.5 Hours or 1.25 Hours) or Ticagrelor Alone (Measured 5.25 Hours After Initiation of Cangrelor on Day 1)
Hide Description A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor and designated the final draw on study Day 1 (5.25 hours, or 3.25 hours after cangrelor had been discontinued) as the reference for the effect of ticagrelor. Residual platelet reactivity (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry. Residual platelet reactivity (PR) was measured in response to 20 µmol adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response).
Time Frame Day 1 measures taken at 2 timepoints after cangrelor infusion start: 0.5 or 1.5 hrs (Timepoint 1) and 5.25 hrs (TImepoint 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients Cangrelor + Ticagrelor 180mg at 1.25 h of Cangrelor Infusion Cangrelor + Ticagrelor 180mg at 0.5 h of Cangrelor Infusion
Hide Arm/Group Description:
[Not Specified]
Cangrelor was administered as IV infusion for 2 hours.
Cangrelor was administered as IV infusion for 2 hours.
Overall Number of Participants Analyzed 12 6 6
Mean (Standard Deviation)
Unit of Measure: percentage of platelet reactivity (PR)
Reference 0.5/1.25 hours - PR 1.7  (1.7) 1.3  (2.0) 2  (1.5)
1.75 hours - PR 2.2  (1.4) 2  (1.8) 2.3  (1.0)
2.0 hours - PR 2.3  (2.2) 1.2  (1.9) 3.5  (1.9)
2.Primary Outcome
Title Extent of Preservation of Inhibitory Effect Compared With Effect Observed During Cangrelor Treatment After Ticagrelor
Hide Description

A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor.

Residual platelet reactivity (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). Residual platelet reactivity (PR) was measured in response to 20 µmol ADP at 300 seconds (final/terminal aggregation response).

Time Frame Day 5 at 1.0 and 2.0 hours after the initiation of cangrelor infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients Ticagrelor Discontinued 24 h Prior to Cangrelor Infusion Ticagrelor Discontinued 12 h Prior to Cangrelor Infusion
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 12 6 6
Mean (Standard Deviation)
Unit of Measure: percentage of platelet reactivity (PR)
1.0 hours - PR 1.5  (1.5) 1.5  (1.6) 1.5  (1.5)
2.0 hours - PR 1.3  (1.6) 1.2  (1.5) 1.5  (1.9)
3.Primary Outcome
Title Extent of Aggregation Response During Ticagrelor Treatment
Hide Description

Blood samples were taken for platelet function studies to conduct pharmacodynamic assessments including LTA.

A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor and designated the final draw on study Day 1 (5.25 hours, or 3.25 hours after cangrelor had been discontinued) as the reference for the effect of ticagrelor.

Residual platelet reactivity (PR) (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry. Residual platelet reactivity was measured in response to 20 µmol ADP at 300 seconds (final/terminal aggregation response).

Time Frame Day 1 at 2.25, 2.5, 2.75, 3 and 4 hrs following initiation of cangrelor infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients Cangrelor + Ticagrelor 180mg at 1.25 h of Cangrelor Infusion Cangrelor + Ticagrelor 180mg at 0.5 h of Cangrelor Infusion
Hide Arm/Group Description:
[Not Specified]
Cangrelor was administered as IV infusion for 2 hours.
Cangrelor was administered as IV infusion for 2 hours.
Overall Number of Participants Analyzed 12 6 6
Mean (Standard Deviation)
Unit of Measure: percentage of platelet reactivity (PR)
Reference 5.25 hours - PR 4  (3.4) 2.2  (2.7) 5.8  (3.1)
2.25 hours - PR 12  (11) 11  (12) 13  (9.3)
2.5 hours - PR 19  (16) 21  (17) 16  (15)
2.75 hours - PR 10  (9.2) 7.8  (7.2) 12  (11)
3 hours - PR 7.1  (6.3) 4.5  (3.4) 10  (7.6)
4 hours - PR 4.6  (3.6) 2.5  (1.9) 6.7  (3.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cangrelor + Ticagrelor 90mg (6 Doses) Cangrelor + Ticagrelor 90mg (7 Doses)
Hide Arm/Group Description Ticagrelor was discontinued 24 h prior to cangrelor infusion Ticagrelor discontinued 12 h prior to cangrelor infusion
All-Cause Mortality
Cangrelor + Ticagrelor 90mg (6 Doses) Cangrelor + Ticagrelor 90mg (7 Doses)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cangrelor + Ticagrelor 90mg (6 Doses) Cangrelor + Ticagrelor 90mg (7 Doses)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cangrelor + Ticagrelor 90mg (6 Doses) Cangrelor + Ticagrelor 90mg (7 Doses)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/6 (16.67%)      1/6 (16.67%)    
General disorders     
Edema peripheral  0/6 (0.00%)  0 1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1/6 (16.67%)  1 0/6 (0.00%)  0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jayne Prats, PhD - VP, Global Knowledge Management
Organization: The Medicines Company
Phone: 888.779.MDCO ext 1510
EMail: jayne.prats@themedco.com
Layout table for additonal information
Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT01766466     History of Changes
Other Study ID Numbers: MDCO-CAN-12-03
First Submitted: January 7, 2013
First Posted: January 11, 2013
Results First Submitted: April 23, 2013
Results First Posted: May 19, 2014
Last Update Posted: May 19, 2014