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Trial record 66 of 397 for:    bleeding episodes

A Safety Study of Eptifibatide in Patients With Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT00834899
Recruitment Status : Terminated (Slow accrual and no cost extension not approved by NHLBI)
First Posted : February 3, 2009
Results First Posted : June 27, 2013
Last Update Posted : June 27, 2013
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Sickle Cell Disease
Interventions Drug: Eptifibatide
Drug: Placebo
Enrollment 13
Recruitment Details Patients with sickle cell disease, admitted with an acute pain episode, and who met eligibility criteria were approached to participate.
Pre-assignment Details Patient who agreed to participate provided informed consent and were screened for eligibility. Eligible patients were subsequently randomized to treatment with eptifibatide or placebo.
Arm/Group Title Eptifibatide Placebo
Hide Arm/Group Description Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours. Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
Period Title: Overall Study
Started 9 4
Completed 8 [1] 3 [2]
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             1
[1]
One patient withdrew consent following completion of the study drug infusion.
[2]
One patient was withdrawn early because she did not meet eligibility criteria.
Arm/Group Title Eptifibatide Placebo Total
Hide Arm/Group Description Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours. Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug. Total of all reporting groups
Overall Number of Baseline Participants 9 4 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 4 participants 13 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
 100.0%
4
 100.0%
13
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 4 participants 13 participants
30.6  (8.78) 34.0  (12.19) 31.6  (9.55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 4 participants 13 participants
Female
6
  66.7%
3
  75.0%
9
  69.2%
Male
3
  33.3%
1
  25.0%
4
  30.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 4 participants 13 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
9
 100.0%
4
 100.0%
13
 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 9 participants 4 participants 13 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
9
 100.0%
4
 100.0%
13
 100.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
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: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 4 participants 13 participants
9 4 13
1.Primary Outcome
Title 1) Major Bleeding Episodes
Hide Description Major bleeding episodes are defined as any episode, such as gastrointestinal bleeding or intracranial bleed that typically leads to hospitalization or other prolonged bleeding requiring a blood transfusion
Time Frame Up to 35 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Eptifibatide Placebo
Hide Arm/Group Description:
Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
Overall Number of Participants Analyzed 9 4
Measure Type: Number
Unit of Measure: participants
0 0
2.Primary Outcome
Title Change in Platelet Count
Hide Description Change in platelet counts occurring anytime from randomization up to day 35 (final follow-up visit).
Time Frame Up to 35 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eptifibatide Placebo
Hide Arm/Group Description:
Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
Overall Number of Participants Analyzed 9 4
Median (Full Range)
Unit of Measure: x 10^9/L
97
(-50 to 410)
-5
(-63 to 129)
3.Secondary Outcome
Title Effect of Eptifibatide on Duration of Acute Pain Episodes
Hide Description

The duration of the pain episode will be defined as the time from randomization to termination of the pain episode. The pain episode will be considered terminated when the patient states that the crisis is resolved (defined as being ready to go home on oral analgesics) or all of the following criteria are met:

  1. Pain relief (pain scores ≤ 40) maintained for at least 2 consecutive readings (assessed using a visual analog scale with measurements from 0 - 100, where 0 is no pain and 100 is worst imaginable pain).
  2. No parenteral analgesics have been administered for at least 12 hours.
  3. Ability to walk normally (unless he/she was unable to walk for some other reason prior to the crisis onset).
Time Frame Up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Eptifibatide Placebo
Hide Arm/Group Description:
Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
Overall Number of Participants Analyzed 9 4
Median (Full Range)
Unit of Measure: Days
3.0
(1.81 to 8.0)
3.0
(0.08 to 3.92)
4.Secondary Outcome
Title Effect of Eptifibatide on Duration of Hospitalization
Hide Description The duration of hospitalization will be defined as the period from randomization to the time an order for discharge from the hospital is written.
Time Frame Up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Eptifibatide Placebo
Hide Arm/Group Description:
Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
Overall Number of Participants Analyzed 9 4
Median (Full Range)
Unit of Measure: Days
3.0
(2.0 to 36.1)
3.0
(2.0 to 4.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Eptifibatide Placebo
Hide Arm/Group Description Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours. Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
All-Cause Mortality
Eptifibatide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Eptifibatide Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/9 (88.89%)      2/4 (50.00%)    
Blood and lymphatic system disorders     
Bacteremia   1/9 (11.11%)  1 0/4 (0.00%)  0
Hypoxemia   1/9 (11.11%)  1 0/4 (0.00%)  0
Sickle Cell Crisis, recurrent   3/9 (33.33%)  4 1/4 (25.00%)  1
Worsening anemia   1/9 (11.11%)  1 0/4 (0.00%)  0
Cardiac disorders     
Acute Chest Syndrome   0/9 (0.00%)  0 1/4 (25.00%)  1
Musculoskeletal and connective tissue disorders     
Shoulder Pain, Left   1/9 (11.11%)  1 0/4 (0.00%)  0
Shoulder Pain, Right   1/9 (11.11%)  1 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Adenovirus Respiratory Infection   1/9 (11.11%)  1 0/4 (0.00%)  0
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%
Eptifibatide Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/9 (77.78%)      3/4 (75.00%)    
Blood and lymphatic system disorders     
Nosebleed   1/9 (11.11%)  1 0/4 (0.00%)  0
Reticulocytosis   1/9 (11.11%)  1 0/4 (0.00%)  0
Sickle Cell Crisis, recurrent   2/9 (22.22%)  2 1/4 (25.00%)  1
Sickle Cell Crisis   1/9 (11.11%)  1 0/4 (0.00%)  0
Thrombocytosis   2/9 (22.22%)  2 0/4 (0.00%)  0
Gastrointestinal disorders     
Constipation   1/9 (11.11%)  1 0/4 (0.00%)  0
Gastrointestinal pain   0/9 (0.00%)  0 1/4 (25.00%)  1
Nausea   3/9 (33.33%)  3 1/4 (25.00%)  1
Vomiting   1/9 (11.11%)  1 0/4 (0.00%)  0
General disorders     
Ankle Swelling, bilateral   0/9 (0.00%)  0 1/4 (25.00%)  1
Excessive perspiration *  0/9 (0.00%)  0 1/4 (25.00%)  1
Sore Throat *  1/9 (11.11%)  1 0/4 (0.00%)  0
Nervous system disorders     
Headache   5/9 (55.56%)  5 2/4 (50.00%)  3
Headache, recurrent   1/9 (11.11%)  1 0/4 (0.00%)  0
Lightheadedness   1/9 (11.11%)  1 0/4 (0.00%)  0
Renal and urinary disorders     
Urinary Retention   0/9 (0.00%)  0 1/4 (25.00%)  2
Urinary Tract Infection   1/9 (11.11%)  1 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Possible Acute Chest Syndrome   1/9 (11.11%)  1 0/4 (0.00%)  0
Upper Respiratory Infection   0/9 (0.00%)  0 1/4 (25.00%)  1
Skin and subcutaneous tissue disorders     
Itching   0/9 (0.00%)  0 1/4 (25.00%)  1
Pruritis   1/9 (11.11%)  1 0/4 (0.00%)  0
Vascular disorders     
Infusion site extravasation   1/9 (11.11%)  1 0/4 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
The study was terminated early resulting in small numbers of subjects analyzed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Name/Title: Kenneth I. Ataga, MD
Organization: University of North Carolina at Chapel Hill
Phone: 919-966-0178
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00834899     History of Changes
Other Study ID Numbers: 1R21HL091265-01A1 ( U.S. NIH Grant/Contract )
First Submitted: January 31, 2009
First Posted: February 3, 2009
Results First Submitted: February 24, 2013
Results First Posted: June 27, 2013
Last Update Posted: June 27, 2013