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Aspirin Prophylaxis in Sickle Cell Disease (START)

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: NCT00178464
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : January 4, 2012
Last Update Posted : November 6, 2017
Sponsor:
Collaborators:
University of Miami
Bayer
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
University of Rochester

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sickle Cell Disease
Intervention Drug: aspirin
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aspirin
Hide Arm/Group Description Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
Period Title: Overall Study
Started 11
Completed 9
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Physician Decision             1
Arm/Group Title Aspirin
Hide Arm/Group Description Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
11
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
7
  63.6%
Male
4
  36.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title Number of Serious Adverse Events
Hide Description Occurrence of individual serious adverse events and relationship to aspirin
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Aspirin
Hide Arm/Group Description:
Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: events
No relationship 6
Unlikely 9
Possible 0
Probable 0
Definite 0
2.Primary Outcome
Title Number of Adverse Events
Hide Description Occurrence of individual adverse events and relationship to aspirin
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Aspirin
Hide Arm/Group Description:
Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: events
No relationship 8
Unlikely 3
Possible 5
Probable 1
Definite 2
3.Secondary Outcome
Title # of Subjects Recruited Over Time, Screening Failures, Withdrawal Rates;Compliance (Pill Counts & Labs);Changes in Performance on Neurocognitive Tests; Changes in MRI/MRA; Changes in TCD;Incidences of Stroke, Acute Chest Crises, and Pain Crises
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aspirin
Hide Arm/Group Description Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
All-Cause Mortality
Aspirin
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Aspirin
Affected / at Risk (%) # Events
Total   8/11 (72.73%)    
Blood and lymphatic system disorders   
Severe Anemia resulting in hospitalization † [1]  1/11 (9.09%)  1
Splenic Sequestration † [2]  1/11 (9.09%)  1
General disorders   
Fever resulting in Hospitalization † [3]  6/11 (54.55%)  7
Musculoskeletal and connective tissue disorders   
Vasoocclusive Crisis Pain resulting in hospitalization † [1]  2/11 (18.18%)  6
Fracture resulting in hospitalization †  1/11 (9.09%)  1
Nervous system disorders   
Abnormal MRA resulting in withdrawal from study. †  1/11 (9.09%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonia resulting in hospitalization †  1/11 (9.09%)  1
Asthma resulting in hospitalization † [1]  1/11 (9.09%)  1
Acute Chest Syndrome resulting in hospitalization. †  1/11 (9.09%)  1
†
Indicates events were collected by systematic assessment
[1]
may be assoc w/other SAEs.
[2]
May be associated w/other SAEs.
[3]
may be in association w/another SAE
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aspirin
Affected / at Risk (%) # Events
Total   8/11 (72.73%)    
Blood and lymphatic system disorders   
Bleeding per rectum †  1/11 (9.09%)  3
Epistaxis †  2/11 (18.18%)  3
Ear and labyrinth disorders   
Otitis Media †  1/11 (9.09%)  1
Gastrointestinal disorders   
Epigastric pain †  1/11 (9.09%)  1
Tarry stool †  1/11 (9.09%)  1
General disorders   
Fever †  2/11 (18.18%)  2
Pain †  3/11 (27.27%)  3
Allergic reaction †  1/11 (9.09%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonia †  1/11 (9.09%)  1
Upper Respiratory Infection †  1/11 (9.09%)  1
Skin and subcutaneous tissue disorders   
Scabies †  1/11 (9.09%)  1
†
Indicates events were collected by systematic assessment
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Dr. Norma B. Lerner
Organization: St. Christopher's Hospital for Children
Phone: 215 427-5261
EMail: norma.lerner@drexelmed.edu
Layout table for additonal information
Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT00178464    
Other Study ID Numbers: 09661
5R01NS045948-03 ( U.S. NIH Grant/Contract )
First Submitted: September 13, 2005
First Posted: September 15, 2005
Results First Submitted: August 9, 2011
Results First Posted: January 4, 2012
Last Update Posted: November 6, 2017