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Trial record 7 of 27 for:    cangrelor

Cangrelor to Clopidogrel or Prasugrel Transition Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01979445
Recruitment Status : Completed
First Posted : November 8, 2013
Results First Posted : March 5, 2018
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
The Medicines Company

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Coronary Artery Disease (CAD)
Interventions Drug: Cangrelor
Drug: Clopidogrel
Drug: Prasugrel
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Prasugrel 30 Min After Cangrelor Clopidogrel Within 5 Min After Cangrelor Clopidogrel 1.5 Hrs During Cangrelor Clopidogrel 1 Hr During Cangrelor
Hide Arm/Group Description

Cangrelor intravenously (IV) was administered on Day 1 as a 30 microgram (μg)/kilogram (kg) bolus, followed by 4 μg/kg/minute (min) infusion for 2 hours (hrs).

Prasugrel 60 milligram (mg) was administered on Day 1 as a single oral dose 30 min after the discontinuation of cangrelor infusion (2.5 hrs after initiation of cangrelor infusion).

Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.

Clopidogrel 600 mg was administered on Day 1 as a single oral dose within 5 min after the discontinuation of the cangrelor infusion (2 hrs after initiation of cangrelor infusion).

Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.

Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1.5 hrs following the initiation of cangrelor infusion.

Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.

Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1 hr following the initiation of cangrelor infusion.

Period Title: Overall Study
Started 3 3 6 3
Received at Least 1 Dose of Study Drug [1] 3 3 6 3
ITT Population [2] 3 3 6 3
Completed 3 3 6 3
Not Completed 0 0 0 0
[1]
Safety Population included all participants who received at least 1 dose of study drug.
[2]
Intent to treat (ITT) Population included all enrolled participants in the study.
Arm/Group Title Prasugrel Clopidogrel Total
Hide Arm/Group Description

Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.

Prasugrel 60 mg was administered on Day 1 as a single oral dose 30 min on Day 1 after the discontinuation of cangrelor infusion.

Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs on Day 1.

Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1 and 1.5 hrs after the initiation of cangrelor infusion and within 5 min after the discontinuation of the cangrelor infusion.

Total of all reporting groups
Overall Number of Baseline Participants 3 12 15
Hide Baseline Analysis Population Description
All participants who received prasugrel or clopidgrel.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 12 participants 15 participants
62.3  (6.66) 65.3  (6.18) 64.7  (6.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 12 participants 15 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
3
 100.0%
12
 100.0%
15
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 12 participants 15 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
3
 100.0%
12
 100.0%
15
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 12 participants 15 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
3
 100.0%
12
 100.0%
15
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 3 participants 12 participants 15 participants
3
 100.0%
12
 100.0%
15
 100.0%
1.Primary Outcome
Title Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor To Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone
Hide Description 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 response).
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants treated with cangrelor and prasugrel or clopidogrel were used for the analysis and presentation of data.
Arm/Group Title Prasugrel 30 Min After Cangrelor Clopidogrel Within 5 Min After Cangrelor Clopidogrel 1.5 Hrs During Cangrelor Clopidogrel 1 Hr During Cangrelor
Hide Arm/Group Description:

Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.

Prasugrel 60 mg was administered on Day 1 as a single oral dose 30 min after the discontinuation of cangrelor infusion (2.5 hrs after initiation of cangrelor infusion).

Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.

Clopidogrel 600 mg was administered on Day 1 as a single oral dose within 5 min after the discontinuation of the cangrelor infusion (2 hrs after initiation of cangrelor infusion).

Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.

Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1.5 hrs following the initiation of cangrelor infusion.

Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.

Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1 hr following the initiation of cangrelor infusion.

Overall Number of Participants Analyzed 3 3 6 3
Mean (Standard Deviation)
Unit of Measure: % aggregation
Prasugrel/Clopidogrel Reference (6 or 5.5 hrs) 1.3  (1.5) 21.7  (16.4) 50.0  (16.8) 50.3  (15.9)
2.25 hrs 16.3  (10.1) 26.0  (7.9) 22.2  (16.0) 33.3  (7.5)
2.5 hrs 60.0  (7.5) 49.7  (7.1) 54.3  (11.7) 62.0  (3.6)
2.75 hrs 63.3  (1.5) 58.3  (7.4) 56.8  (11.3) 67.7  (1.2)
3 hrs 65.0  (2.0) 56.0  (8.9) 56.2  (16.4) 65.0  (9.5)
4 hrs 16.3  (27.4) 38.0  (31.7) 51.2  (27.4) 62.7  (8.5)
5.5 hrs 1.3  (1.5) 26.7  (20.5) NA [1]   (NA) NA [1]   (NA)
[1]
Per protocol, analysis was not performed at 5.5 hrs for this arm.
2.Primary Outcome
Title Extent Of Preservation Of Platelet Inhibitory Effect Of Cangrelor Treatment After Prasugrel Or Clopidogrel Compared To Treatment With Cangrelor Alone
Hide Description 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).
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants treated with cangrelor and prasugrel or clopidogrel were used for the analysis and presentation of data.
Arm/Group Title Prasugrel 30 Min After Cangrelor Clopidogrel Within 5 Min After Cangrelor Clopidogrel 1.5 Hrs During Cangrelor Clopidogrel 1 Hr During Cangrelor
Hide Arm/Group Description:

Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.

Prasugrel 60 mg was administered on Day 1 as a single oral dose 30 min after the discontinuation of cangrelor infusion (2.5 hrs after initiation of cangrelor infusion).

Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.

Clopidogrel 600 mg was administered on Day 1 as a single oral dose within 5 min after the discontinuation of the cangrelor infusion (2 hrs after initiation of cangrelor infusion).

Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.

Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1.5 hrs following the initiation of cangrelor infusion.

Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1 hr following the initiation of cangrelor infusion.

Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.

Overall Number of Participants Analyzed 3 3 6 3
Mean (Standard Deviation)
Unit of Measure: % aggregation
Cangrelor Reference (2.5, 2, 1.5, or 1 hrs) 60.0  (7.5) 0  (0) 2.0  (3.5) 3.0  (2.0)
1.75 hrs 0.3  (0.6) 1.0  (1.0) 1.8  (2.5) 1.3  (0.6)
2 hrs 0.3  (0.6) NA [1]   (NA) 1.5  (2.0) 2.3  (1.2)
[1]
Per protocol, analysis was not performed at 2 hrs for this arm.
3.Secondary Outcome
Title 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
Hide Description 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 directly measure the effects of drugs on the P2Y12 receptor, using prostaglandin E1 in addition to ADP to increase intraplatelet cyclic adenosine monophosphate (cAMP). Platelet reactivity was expressed in PRU.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants treated with cangrelor and prasugrel or clopidogrel were used for the analysis and presentation of data.
Arm/Group Title Prasugrel 30 Min After Cangrelor Clopidogrel Within 5 Min Post Cangrelor Clopidogrel 1.5 Hrs During Cangrelor Clopidogrel 1 Hr During Cangrelor
Hide Arm/Group Description:

Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.

Prasugrel 60 mg was administered on Day 1 as a single oral dose 30 min after the discontinuation of cangrelor infusion (2.5 hrs after initiation of cangrelor infusion).

Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.

Clopidogrel 600 mg was administered on Day 1 as a single oral dose within 5 min after the discontinuation of the cangrelor infusion (2 hrs after initiation of cangrelor infusion).

Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.

Clopidogrel 600 mg administered on Day 1 as a single oral dose 1.5 hrs following the initiation of cangrelor infusion.

Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.

Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1 hr following the initiation of cangrelor infusion.

Overall Number of Participants Analyzed 3 3 6 3
Mean (Standard Deviation)
Unit of Measure: PRU
Prasugrel/Clopidogrel Reference (6 or 5.5 hrs) 8.0  (8.7) 159.0  (72.7) 211.3  (66.8) 197.3  (15.0)
2.25 hrs 76.7  (23.7) 99.0  (27.6) 90.3  (32.3) 98.7  (19.6)
2.5 hrs 208.0  (30.2) 220.7  (11.6) 229.8  (24.6) 206.3  (26.9)
2.75 hrs 225.7  (42.5) 233.0  (21.7) 255.8  (43.7) 214.3  (11.9)
3 hrs 226.0  (28.5) 215.7  (35.0) 234.5  (34.2) 212.7  (10.3)
4 hrs 77.0  (126.5) 182.0  (82.3) 215.5  (67.4) 203.7  (11.2)
5.5 hrs 24.5  (34.6) 155.0  (69.8) NA [1]   (NA) NA [1]   (NA)
[1]
Per protocol, analysis was not performed for this arm at 5.5 hrs.
4.Secondary Outcome
Title 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
Hide Description 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 prostaglandin E1 in addition to ADP to increase intraplatelet cAMP. Platelet reactivity was expressed in PRU.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants treated with cangrelor and prasugrel or clopidogrel were used for the analysis and presentation of data.
Arm/Group Title Prasugrel 30 Min After Cangrelor Clopidogrel Within 5 Min After Cangrelor Clopidogrel 1.5 Hrs During Cangrelor Clopidogrel 1 Hr During Cangrelor
Hide Arm/Group Description:

Prasugrel 60 mg was administered orally 30 min after the discontinuation of cangrelor infusion (2.5 hrs after initiation of cangrelor infusion).

Cangrelor IV was administered as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs on study Day 1.

Clopidogrel 600 mg was administered orally within 5 min after the discontinuation of the cangrelor infusion (2 hrs after initiation of cangrelor infusion).

Cangrelor IV was administered as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs on study Day 1.

Clopidogrel 600 mg administered orally 1.5 hrs following the initiation of cangrelor infusion.

Cangrelor IV was administered as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs on study Day 1.

Clopidogrel 600 mg administered orally 1 hr following the initiation of cangrelor infusion.

Cangrelor IV was administered as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs on study Day 1.

Overall Number of Participants Analyzed 3 3 6 3
Mean (Standard Deviation)
Unit of Measure: PRU
Cangrelor Reference (2.5, 2, 1.5, or 1 hrs) 208.0  (30.2) 7.3  (5.1) 17.7  (18.2) 7.0  (2.0)
1.75 hrs 3.3  (2.3) 3.7  (2.1) 25.0  (30.5) 6.3  (1.5)
2 hrs 5.3  (2.1) NA [1]   (NA) 28.8  (18.2) 5.7  (2.1)
[1]
Per protocol, analysis was not performed for this arm at 2 hrs.
5.Secondary Outcome
Title Bleeding Events In Accordance With GUSTO Scale
Hide Description

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 serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

Time Frame Screening through the follow-up period (5 to 7 days after Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants who received at least 1 dose of study drug.
Arm/Group Title Prasugrel 30 Min After Cangrelor Clopidogrel Within 5 Min After Cangrelor Clopidogrel 1.5 Hrs During Cangrelor Clopidogrel 1 Hr During Cangrelor
Hide Arm/Group Description:

Prasugrel 60 mg was administered on Day 1 as a single oral dose 30 min after the discontinuation of cangrelor infusion (2.5 hrs after initiation of cangrelor infusion).

Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.

Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.

Clopidogrel 600 mg was administered on Day 1 as a single oral dose within 5 min after the discontinuation of the cangrelor infusion (2 hrs after initiation of cangrelor infusion).

Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.

Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1.5 hrs following the initiation of cangrelor infusion.

Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.

Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1 hr following the initiation of cangrelor infusion.

Overall Number of Participants Analyzed 3 3 6 3
Measure Type: Number
Unit of Measure: bleeding events
Mild 0 0 0 0
Moderate 0 0 0 0
Life-threatening/Severe 0 0 0 0
Time Frame Screening through the follow-up period (5 to 7 days after Day 1)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Prasugrel 30 Min After Cangrelor Clopidogrel Within 5 Min After Cangrelor Clopidogrel 1.5 Hrs During Cangrelor Clopidogrel 1 Hr During Cangrelor
Hide Arm/Group Description

Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.

Prasugrel 60 mg was administered on Day 1 as a single oral dose 30 min after the discontinuation of cangrelor infusion (2.5 hrs after initiation of cangrelor infusion).

Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.

Clopidogrel 600 mg was administered on Day 1 as a single oral dose within 5 min after the discontinuation of the cangrelor infusion (2 hrs after initiation of cangrelor infusion).

Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.

Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1.5 hrs following the initiation of cangrelor infusion.

Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.

Clopidogrel 600 mg administered on Day 1 as a single oral dose 1 hr following the initiation of cangrelor infusion.

All-Cause Mortality
Prasugrel 30 Min After Cangrelor Clopidogrel Within 5 Min After Cangrelor Clopidogrel 1.5 Hrs During Cangrelor Clopidogrel 1 Hr During Cangrelor
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%)   0/6 (0.00%)   0/3 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Prasugrel 30 Min After Cangrelor Clopidogrel Within 5 Min After Cangrelor Clopidogrel 1.5 Hrs During Cangrelor Clopidogrel 1 Hr During Cangrelor
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%)   0/6 (0.00%)   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Prasugrel 30 Min After Cangrelor Clopidogrel Within 5 Min After Cangrelor Clopidogrel 1.5 Hrs During Cangrelor Clopidogrel 1 Hr During Cangrelor
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%)   0/6 (0.00%)   0/3 (0.00%) 
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: Global Health Science Center, The Medicines Company
Organization: The Medicines Company
Phone: 1-888-977-6326
EMail: medical.information@themedco.com
Layout table for additonal information
Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT01979445     History of Changes
Other Study ID Numbers: MDCO-CAN-13-02
First Submitted: November 1, 2013
First Posted: November 8, 2013
Results First Submitted: December 16, 2017
Results First Posted: March 5, 2018
Last Update Posted: March 5, 2018