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Trial record 19 of 123 for:    IK

Significance of Antibodies to Heparin/Platelet Factor 4 Complex in Vein Graft Patency and Potential Role of Argatroban for Prevention of Vein Graft Occlusion

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ClinicalTrials.gov Identifier: NCT01246011
Recruitment Status : Terminated (Enrollment was too slow.)
First Posted : November 23, 2010
Results First Posted : March 12, 2012
Last Update Posted : November 17, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Coronary Artery Bypass Graft Surgery
Presence of Heparin/Platelet Factor 4 Antibody
Intervention Drug: Argatroban and warfarin
Enrollment 9
Recruitment Details The study began enrolling in January 2011 and screening ended in July 2011, after it was decided that enrollment was too slow and that the study should be terminated.
Pre-assignment Details  
Arm/Group Title Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin) Heparin PF4 Antibody Positive no Drug Heparin PF4 Antibody Negative
Hide Arm/Group Description Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication Post-CABG heparin PF4 antibody negative with no signs or symptoms of HIT randomized to receive no medication
Period Title: Overall Study
Started 0 0 9
Completed 0 0 5
Not Completed 0 0 4
Reason Not Completed
If needed warfarin clinically, withdrawn             0             0             3
Withdrawal by Subject             0             0             1
Arm/Group Title Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin) Heparin PF4 Antibody Positive no Drug Heparin PF4 Antibody Negative Total
Hide Arm/Group Description Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication Post-CABG heparin PF4 antibody negative with no signs or symptoms of HIT randomized to receive no medication Total of all reporting groups
Overall Number of Baseline Participants 0 0 9 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 9 participants 9 participants
<=18 years
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  55.6%
5
  55.6%
>=65 years
4
  44.4%
4
  44.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 0 participants 0 participants 9 participants 9 participants
61.9  (11.3) 61.9  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 9 participants 9 participants
Female
1
  11.1%
1
  11.1%
Male
8
  88.9%
8
  88.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 0 participants 0 participants 9 participants 9 participants
9 9
1.Primary Outcome
Title Coronary Artery Bypass Vein Graft Patency
Hide Description Vein graft patency as measured by computed tomography
Time Frame Approximately 30 Days post CABG
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis will be done due to early study termination
Arm/Group Title Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin) Heparin PF4 Antibody Positive no Drug Heparin PF4 Antibody Negative
Hide Arm/Group Description:
Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin
Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication
Post-CABG heparin PF4 antibody negative with no signs or symptoms of HIT randomized to receive no medication
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Major Bleeding Events.
Hide Description Intracranial bleed or any clinically overt sign of hemorrhage that is associated with a fall in hemoglobin > 5 g/dL.
Time Frame At 2weeks post CABG
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis will be done due to early study termination.
Arm/Group Title Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin) Heparin PF4 Antibody Positive no Drug Heparin PF4 Antibody Negative
Hide Arm/Group Description:

Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin

Argatroban and warfarin: Subjects with the presence of heparin PF4 antibodies without signs or symptoms of HIT post CABG will be randomized to receive argatroban and warfarin or no drug for one month.

Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication
Post-CABG heparin PF4 antibody negative with no signs or symptoms of HIT randomized to receive no medication
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 month
Adverse Event Reporting Description 1 subject withdrew from the study prior to having a specimen drawn, so there were only 8 participants at risk
 
Arm/Group Title Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin) Heparin PF4 Antibody Positive no Drug Heparin PF4 Antibody Negative
Hide Arm/Group Description Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication Post-CABG heparin PF4 antibody negative with no signs or symptoms of HIT randomized to receive no medication
All-Cause Mortality
Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin) Heparin PF4 Antibody Positive no Drug Heparin PF4 Antibody Negative
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin) Heparin PF4 Antibody Positive no Drug Heparin PF4 Antibody Negative
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0      5/8 (62.50%)    
Cardiac disorders       
Atrial Fibrillation after Coronary Artery Bypass Surgery   0/0  0 0/0  0 3/8 (37.50%)  3
Bleeding during or immediately after Coronary Artery Bypass Surgery   0/0  0 0/0  0 2/8 (25.00%)  2
Vascular disorders       
Hypotension after Coronary Artery Bypass Graft Surgery   0/0  0 0/0  0 2/8 (25.00%)  2
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin) Heparin PF4 Antibody Positive no Drug Heparin PF4 Antibody Negative
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0      5/8 (62.50%)    
Cardiac disorders       
Low Hematocrit after Coronary Artery Bypass Graft Surgery   0/0  0 0/0  0 4/8 (50.00%)  4
Pericarditis   0/0  0 0/0  0 1/8 (12.50%)  1
Gastrointestinal disorders       
Post operative nausea   0/0  0 0/0  0 1/8 (12.50%)  1
Musculoskeletal and connective tissue disorders       
Back spasm   0/0  0 0/0  0 1/8 (12.50%)  1
Nervous system disorders       
Parkinson's-like features   0/0  0 0/0  0 1/8 (12.50%)  1
Renal and urinary disorders       
Urinary Retention after Coronary Artery Bypass Surgery   0/0  0 0/0  0 1/8 (12.50%)  1
Indicates events were collected by systematic assessment
The study was ended early due to slow enrollment and results will not be analyzed. The 4 subjects who completed the study were all in the same arm of the study.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Anne Philip, Data Manager
Organization: Massachusetts General Hospital
Phone: 617 726 0423
Responsible Party: Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01246011     History of Changes
Other Study ID Numbers: 2010P001386
First Submitted: November 17, 2010
First Posted: November 23, 2010
Results First Submitted: January 3, 2012
Results First Posted: March 12, 2012
Last Update Posted: November 17, 2017