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Trial record 4 of 27 for:    cangrelor

Cangrelor Prasugrel Transition Study

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ClinicalTrials.gov Identifier: NCT01852019
Recruitment Status : Completed
First Posted : May 13, 2013
Results First Posted : May 28, 2015
Last Update Posted : June 24, 2015
Sponsor:
Information provided by (Responsible Party):
The Medicines Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Coronary Artery Disease
Interventions Drug: Cangrelor
Drug: Prasugrel
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h Day 8 - Prasugrel (10mg) Dosing (5 Doses) Day 8 - Prasugrel (10mg) Dosing (6 Doses)
Hide Arm/Group Description

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

cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.

Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.

Cangrelor IV + oral prasugrel (60mg) administered at 1.0h after the cangrelor infusion start time.

cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.

Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.

Cangrelor IV + oral prasugrel (60mg) administered at 1.5h after the cangrelor infusion start time.

cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.

Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.

Prasugrel discontinued 48h (n=6) prior to initiation of cangrelor infusion (2h)

cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.

Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.

Prasugrel discontinued 24h prior to initiation of cangrelor infusion (2h)

cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.

Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.

Period Title: Day 1
Started 3 3 6 0 0
Completed 3 3 6 0 0
Not Completed 0 0 0 0 0
Period Title: Day 8
Started 0 0 0 6 6
Completed 0 0 0 6 6
Not Completed 0 0 0 0 0
Arm/Group Title Day 8 - Prasugrel (10mg) Dosing (6 Doses) Day 8 - Prasugrel (10mg) Dosing (5 Doses) Total
Hide Arm/Group Description

Prasugrel discontinued 24h prior to initiation of cangrelor infusion (2h)

Cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.

Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.

Prasugrel discontinued 48h prior to initiation of cangrelor infusion (2h)

Cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.

Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.

Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
62.3  (6.47) 67.3  (4.37) 64.8  (5.87)
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%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 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
6
 100.0%
6
 100.0%
12
 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%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
6
 100.0%
6
 100.0%
12
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
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 After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)
Hide Description 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).
Time Frame Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures.
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.
Arm/Group Title Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h) Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h
Hide Arm/Group Description:

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

cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.

Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.

Cangrelor IV + oral prasugrel (60mg) was administered at 1.5h after the cangrelor infusion start time.

cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.

Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.

Cangrelor IV + oral prasugrel (60mg) were administered at 1.0h after the cangrelor infusion start time.

cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.

Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.

Overall Number of Participants Analyzed 3 6 3
Mean (Standard Deviation)
Unit of Measure: % aggregation
Prasugrel Reference (6.0h or 5.5 h) 1.0  (1.0) 2.8  (3.1) 5.0  (6.2)
2.25 h 27  (20) 25  (15) 45  (24)
2.5 h 56  (6.7) 42  (27) 62  (3.8)
2.75 h 64  (2.1) 31  (33) 69  (4.6)
3.0 h 58  (14) 24  (26) 51  (5.1)
4.0 h 1.0  (1.7) 10  (15) 15  (18)
2.Primary Outcome
Title Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone
Hide Description 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).
Time Frame Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.
Arm/Group Title Day 8 - Prasugrel (10mg) Dosing (6 Doses) Day 8 - Prasugrel (10mg) Dosing (5 Doses)
Hide Arm/Group Description:

Prasugrel was discontinued 24h prior to initiation of cangrelor infusion (2h)

Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.

Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.

Prasugrel was discontinued 48h prior to initiation of cangrelor infusion (2h)

Cangrelor: Cangrelor IV iwas administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.

Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.

Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: % aggregation
1.0 h 0.5  (0.8) 1.3  (2.0)
2.0 h 0.0  (0.0) 1.0  (1.4)
3.Secondary Outcome
Title Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)
Hide Description 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 of absence of the study drugs was examined for each of the endpoints as assessed by platelet reaction units (PRU) from the VerifyNow P2Y12 assay.
Time Frame Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures.
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.
Arm/Group Title Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h) Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h
Hide Arm/Group Description:

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

cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.

Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.

Cangrelor IV + oral prasugrel (60mg) was administered at 1.5h after the cangrelor infusion start time.

cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.

Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.

Cangrelor IV + oral prasugrel (60mg) were administered at 1.0h after the cangrelor infusion start time.

cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.

Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.

Overall Number of Participants Analyzed 3 6 3
Mean (Standard Deviation)
Unit of Measure: platelet reaction units (PRU)
Prasugrel Reference (6.0h or 5.5h) - PRU 7.7  (12) 41  (42) 74  (60)
2.25h - PRU 91  (82) 82  (39) 151  (77)
2.5h - PRU 242  (50) 181  (70) 269  (38)
2.75h - PRU 267  (25) 134  (94) 285  (35)
3.0h - PRU 239  (50) 127  (124) 242  (32)
4.0h - PRU 20  (31) 56  (68) 117  (77)
4.Secondary Outcome
Title Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone
Hide Description 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 as assessed by platelet reaction units (PRU) from the VerifyNow P2Y12 assay.
Time Frame Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.
Arm/Group Title Day 8 - Prasugrel (10mg) Dosing (6 Doses) Day 8 - Prasugrel (10mg) Dosing (5 Doses)
Hide Arm/Group Description:

Prasugrel was discontinued 24h prior to initiation of cangrelor infusion (2h)

Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.

Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.

Prasugrel was discontinued 48h prior to initiation of cangrelor infusion (2h)

Cangrelor: Cangrelor IV iwas administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.

Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.

Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: platelet reaction units (PRU)
1.0 h - PRU 6.3  (6.6) 8.3  (5.4)
2.0 h - PRU 4.7  (2.6) 13  (18)
5.Secondary Outcome
Title Bleeding Events in Accordance With the GUSTO Scale
Hide Description Bleeding was assessed by history, physical exam, and complete blood count (CBC) that was performed on study Days 1 and 8. Reports of bleeding were to be evaluated by performance of a CBC. Bleeding was to be reported as recommended and quantified in accordance with the GUSTO criteria [The GUSTO Investigators, 1993].
Time Frame Day 1 through Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Day 8 - Prasugrel (10mg) Dosing (6 Doses) Day 8 - Prasugrel (10mg) Dosing (5 Doses)
Hide Arm/Group Description:

Prasugrel was discontinued 24h prior to initiation of cangrelor infusion (2h)

Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.

Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.

Prasugrel was discontinued 48h prior to initiation of cangrelor infusion (2h)

Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.

Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.

Overall Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: participants
Mild 1 0
Moderate 0 0
Life-threatening/Severe 0 0
Time Frame Screening through Follow-up Period
Adverse Event Reporting Description

Follow-up period:

Each subject was contacted by telephone 5 to 7 days after Study Day 8 to assess adverse event (AEs) / serious adverse events (SAEs) and to ensure that any previously identified AEs/SAEs had resolved.

 
Arm/Group Title Day 1 - Prasugrel (60mg) at 1.5 Hrs Day 1 - Prasugrel (60mg) at 1.0 hr Day 1 - Prasugrel (60mg) - Post Infusion (2.0 hr) Day 8 - Prasugrel (10mg) Dosing (6 Doses) Day 8 - Prasugrel (10mg) Dosing (5 Doses)
Hide Arm/Group Description

Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel: Day 1: Subjects received prasugrel (60 mg) during the initial cangrelor infusion (at 1.5 hours after infusion start).

Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel: Day 1: Subjects received prasugrel (60 mg) during the initial cangrelor infusion (at 1.0 hour after infusion start).

Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel: Day 1: Subjects received prasugrel (60 mg) post infusion, [at 2.0 hrs, (within 5 minutes of discontinuing the cangrelor infusion)].

Prasugrel was discontinued 24h prior to initiation of cangrelor infusion (2h)

Subjects were given 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.

Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel was discontinued 48h prior to initiation of cangrelor infusion (2h)

Subjects were given 5 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.

Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

All-Cause Mortality
Day 1 - Prasugrel (60mg) at 1.5 Hrs Day 1 - Prasugrel (60mg) at 1.0 hr Day 1 - Prasugrel (60mg) - Post Infusion (2.0 hr) Day 8 - Prasugrel (10mg) Dosing (6 Doses) Day 8 - Prasugrel (10mg) Dosing (5 Doses)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Day 1 - Prasugrel (60mg) at 1.5 Hrs Day 1 - Prasugrel (60mg) at 1.0 hr Day 1 - Prasugrel (60mg) - Post Infusion (2.0 hr) Day 8 - Prasugrel (10mg) Dosing (6 Doses) Day 8 - Prasugrel (10mg) Dosing (5 Doses)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      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%
Day 1 - Prasugrel (60mg) at 1.5 Hrs Day 1 - Prasugrel (60mg) at 1.0 hr Day 1 - Prasugrel (60mg) - Post Infusion (2.0 hr) Day 8 - Prasugrel (10mg) Dosing (6 Doses) Day 8 - Prasugrel (10mg) Dosing (5 Doses)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/6 (33.33%)      0/3 (0.00%)      0/3 (0.00%)      0/6 (0.00%)      0/6 (0.00%)    
Gastrointestinal disorders           
Diarrhoea  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
General disorders           
Infusion site hemmorrhage [1]  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
[1]
General disorders and administrations site conditions
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.
Prior to submission for publication or presentation, the Institution will provide the Sponsor thirty (30) days for review and comment, If necessary, Sponsor will be given an additional sixty (60) days to allow Sponsor to file a patent application or taking such other measures as Sponsor deems appropriate to establish and preserve its proprietary rights upon the manuscript or other material for such publication. Sponsor may remove confidential or proprietary information.
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: NCT01852019     History of Changes
Other Study ID Numbers: MDCO-CAN-13-01
First Submitted: May 6, 2013
First Posted: May 13, 2013
Results First Submitted: August 1, 2014
Results First Posted: May 28, 2015
Last Update Posted: June 24, 2015