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Efficacy And Safety Of Clopidogrel In Neonates /Infants With Systemic To Pulmonary Artery Shunt Palliation (CLARINET)

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ClinicalTrials.gov Identifier: NCT00396877
Recruitment Status : Completed
First Posted : November 8, 2006
Results First Posted : March 11, 2011
Last Update Posted : October 24, 2014
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Heart Defects, Congenital
Interventions Drug: Clopidogrel (SR25990)
Drug: placebo
Enrollment 906
Recruitment Details Recruitment was initially planned with a minimum of 490 participants anticipating that it would continue until a total of 172 participants reaching primary endpoint criteria is achieved. Finally 906 participants were enrolled and randomized between November 2006 and October 2009 in 134 sites in 31 countries. Actual median follow-up was 5.8 months.
Pre-assignment Details A participant was considered randomized when informed consent had been obtained and there was confirmation of successful allocation of a randomization number through the study treatment allocation system (Interactive Voice Response System).
Arm/Group Title Placebo Clopidogrel 0.2 mg/kg/Day
Hide Arm/Group Description Reconstituted solution using Clopidogrel matching placebo powder administered once daily with a graduated syringe in the mouth or via a feeding tube.

Reconstituted solution using Clopidogrel powder administered once daily with a graduated syringe in the mouth or via a feeding tube.

Route: oral or enteric

Frequency: once daily

Dose: daily dose adjusted for weight

Period Title: Overall Study
Started 439 [1] 467 [1]
Treated 436 464
Completed Treatment 356 352
Completed 433 [2] 459 [2]
Not Completed 6 8
Reason Not Completed
Lost to Follow-up             2             1
Parent(s)/guardian(s)'s request             4             7
[1]
Randomized
[2]
Completed follow-up
Arm/Group Title Placebo Clopidogrel 0.2 mg/kg/Day Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 439 467 906
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 439 participants 467 participants 906 participants
36.0  (22.5) 36.1  (22.3) 36.1  (22.4)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 439 participants 467 participants 906 participants
≤ 30 days 223 238 461
30 (<) - 92 days 216 229 445
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 439 participants 467 participants 906 participants
Female
185
  42.1%
198
  42.4%
383
  42.3%
Male
254
  57.9%
269
  57.6%
523
  57.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 439 participants 467 participants 906 participants
United States 90 88 178
Portugal 10 10 20
Taiwan 12 10 22
Hong Kong 1 0 1
Thailand 2 3 5
Spain 16 14 30
Israel 3 4 7
Russian Federation 13 15 28
Italy 20 19 39
India 20 27 47
France 11 10 21
Malaysia 5 4 9
Denmark 3 3 6
South Africa 13 13 26
Netherlands 2 4 6
China 10 11 21
Korea, Republic of 3 2 5
Finland 2 1 3
United Kingdom 16 16 32
Egypt 4 6 10
Hungary 9 9 18
Mexico 32 37 69
Canada 5 6 11
Argentina 24 28 52
Brazil 31 34 65
Belgium 9 12 21
Poland 3 7 10
Singapore 2 2 4
Germany 54 59 113
Norway 8 8 16
Sweden 6 5 11
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)
Number Analyzed 439 participants 467 participants 906 participants
3.5  (0.7) 3.4  (0.7) 3.5  (0.7)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters (cm)
Number Analyzed 439 participants 467 participants 906 participants
51.8  (4.6) 51.4  (4.4) 51.6  (4.5)
Type of systemic-to-pulmonary artery shunt palliation   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 439 participants 467 participants 906 participants
Modified Blalock Taussig Shunt with Norwood 51 62 113
Modified Blalock Taussig Shunt without Norwood 252 257 509
Sano procedure with Norwood 54 60 114
Sano procedure without Norwood 2 5 7
Central shunt 38 40 78
Stent of ductus arteriosus 42 42 84
Not applicable 0 1 1
[1]
Measure Description: One participant didn't have a systemic-to-pulmonary artery shunt but underwent stenting of the right ventricular outflow track.
Shunt on cardiopulmonary bypass  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 439 participants 467 participants 906 participants
Yes 177 194 371
No 262 273 535
Age at shunt palliation  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 439 participants 467 participants 906 participants
16.0  (18.7) 16.2  (18.6) 16.1  (18.7)
Time from shunt palliation to randomization  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 439 participants 467 participants 906 participants
≤ 1 week 116 113 229
1 (<) to 2 weeks 105 126 231
2 (<) to 4 weeks 117 119 236
> 4 weeks 101 109 210
1.Primary Outcome
Title Number of Participants Reaching Primary Endpoint Criteria (First Occurrence of Death / Shunt Thrombosis / Cardiac Procedure < 120 Days Considered of Thrombotic Nature)
Hide Description

The primary endpoint was the first occurence of any of the following events: Death (including heart transplant); Shunt thrombosis requiring intervention; Hospitalization for bi-directional Glenn procedure or any cardiac related intervention prior to 120 days of age following an event or a shunt narrowing considered to be of thrombotic nature by the blinded adjudication committee.

Only the first event was counted.

Time Frame Median follow-up of 5.8 months (up to a maximum of 12 months after randomization)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the intent-to-treat (ITT) population (i.e. all randomized participants irrespective of whether or not the participant actually received study drug or the participant's compliance with the study protocol). Participants were included in the treatment group to which they were originally allocated.
Arm/Group Title Placebo Clopidogrel 0.2 mg/kg/Day
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 439 467
Measure Type: Number
Unit of Measure: participants
Death / Shunt Thrombosis / Cardiac Procedure 90 89
- Death 60 51
- Shunt thrombosis 21 26
- Cardiac procedure <120 days of thrombotic nature 9 12
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Clopidogrel 0.2 mg/kg/Day
Comments

Due to the limited knowledge in this population, 3 interim analyses were performed at approximatively 40%, 60%, 80% and 100% of of the maximum number of 172 required primary efficacy events to evaluate the effect of Clopidogrel on the primary endpoint with the potential to end the trial in case of a clear efficacy advantage for Clopidogrel.

The study was designed with 80% power and an overall type I error rate of 5%.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4340
Comments The a-priori threshold for statistical significance was < 0.035 reflecting the adjustment for interim analyses. No other adjustment for multiplicity was made.
Method Log Rank
Comments A two-sided log-rank test was used.
Method of Estimation Estimation Parameter Relative Risk Reduction (%)
Estimated Value 11.1
Confidence Interval (2-Sided) 95%
-19.2 to 33.6
Estimation Comments The Relative Risk Reduction (Clopidogrel versus placebo) and its corresponding 95% confidence interval were estimated using Cox's proportional hazards model.
2.Secondary Outcome
Title Number of Participants With Bleeding Events
Hide Description

Bleeding events spanning from signature of the Informed Consent Form up to the last visit were collected as for any Adverse Event.

The 'on-treatment' period was defined as the period from randomization up until 28 days after treatment discontinuation or final follow-up visit, whichever came first, and participants who experienced bleeding events during that period were counted.

Time Frame From randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever comes first
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the exposed population (i.e. all randomized participants who received at least one dose of study drug regardless of the amount of treatment received). Participants were included in the treatment group according to the treatment received.
Arm/Group Title Placebo Clopidogrel 0.2 mg/kg/Day
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 436 464
Measure Type: Number
Unit of Measure: participants
Any bleeding event 88 87
- Serious 32 30
- Serious with an outcome of death 1 1
- Leading to permanent treatment discontinuation 9 9
3.Secondary Outcome
Title Number of Participants According to Bleeding Type/Etiology
Hide Description For all reported bleeding events, the type and the etiology of the bleeding event were collected. Participants who experienced bleeding events during the 'on-treatment period' were counted by bleeding type and etiology. Participants who had multiple bleedings could be counted several times.
Time Frame From randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever comes first
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the same population as previously (i.e. exposed population).
Arm/Group Title Placebo Clopidogrel 0.2 mg/kg/Day
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 436 464
Measure Type: Number
Unit of Measure: participants
Spontaneous 60 56
Post-traumatic 6 11
Puncture (vascular access site) 19 9
Surgical 10 17
Time Frame All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
Adverse Event Reporting Description The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
 
Arm/Group Title Placebo Clopidogrel 0.2mg/kg/Day
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Placebo Clopidogrel 0.2mg/kg/Day
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Clopidogrel 0.2mg/kg/Day
Affected / at Risk (%) Affected / at Risk (%)
Total   196/436 (44.95%)   234/464 (50.43%) 
Blood and lymphatic system disorders     
ANAEMIA  1  3/436 (0.69%)  2/464 (0.43%) 
THROMBOCYTOPENIA  1  1/436 (0.23%)  2/464 (0.43%) 
DEFICIENCY ANAEMIA  1  0/436 (0.00%)  1/464 (0.22%) 
DISSEMINATED INTRAVASCULAR COAGULATION  1  1/436 (0.23%)  0/464 (0.00%) 
HAEMORRHAGIC ANAEMIA  1  1/436 (0.23%)  0/464 (0.00%) 
Cardiac disorders     
CYANOSIS  1  9/436 (2.06%)  24/464 (5.17%) 
PERICARDIAL EFFUSION  1  1/436 (0.23%)  4/464 (0.86%) 
CARDIAC FAILURE  1  5/436 (1.15%)  6/464 (1.29%) 
BRADYCARDIA  1  4/436 (0.92%)  3/464 (0.65%) 
CARDIAC FAILURE CONGESTIVE  1  2/436 (0.46%)  4/464 (0.86%) 
CARDIAC ARREST  1  2/436 (0.46%)  3/464 (0.65%) 
CARDIO-RESPIRATORY ARREST  1  1/436 (0.23%)  4/464 (0.86%) 
SUPRAVENTRICULAR TACHYCARDIA  1  2/436 (0.46%)  3/464 (0.65%) 
RIGHT VENTRICULAR DYSFUNCTION  1  0/436 (0.00%)  2/464 (0.43%) 
ARRHYTHMIA  1  0/436 (0.00%)  2/464 (0.43%) 
ATRIOVENTRICULAR BLOCK  1  0/436 (0.00%)  2/464 (0.43%) 
CARDIAC PERFORATION  1  0/436 (0.00%)  1/464 (0.22%) 
ATRIOVENTRICULAR BLOCK COMPLETE  1  1/436 (0.23%)  0/464 (0.00%) 
CARDIAC DISORDER  1  0/436 (0.00%)  1/464 (0.22%) 
CARDIAC FAILURE ACUTE  1  0/436 (0.00%)  1/464 (0.22%) 
CARDIAC PSEUDOANEURYSM  1  0/436 (0.00%)  1/464 (0.22%) 
CARDIOGENIC SHOCK  1  2/436 (0.46%)  1/464 (0.22%) 
CARDIOPULMONARY FAILURE  1  0/436 (0.00%)  1/464 (0.22%) 
DILATATION VENTRICULAR  1  0/436 (0.00%)  1/464 (0.22%) 
LEFT VENTRICULAR DYSFUNCTION  1  0/436 (0.00%)  1/464 (0.22%) 
PERICARDIAL HAEMORRHAGE  1  1/436 (0.23%)  1/464 (0.22%) 
PULMONARY VALVE STENOSIS  1  3/436 (0.69%)  1/464 (0.22%) 
RIGHT VENTRICULAR FAILURE  1  0/436 (0.00%)  1/464 (0.22%) 
SUPRAVENTRICULAR EXTRASYSTOLES  1  0/436 (0.00%)  1/464 (0.22%) 
TACHYCARDIA  1  1/436 (0.23%)  0/464 (0.00%) 
VENTRICULAR ARRHYTHMIA  1  0/436 (0.00%)  1/464 (0.22%) 
VENTRICULAR FIBRILLATION  1  0/436 (0.00%)  1/464 (0.22%) 
LOW CARDIAC OUTPUT SYNDROME  1  2/436 (0.46%)  0/464 (0.00%) 
NODAL ARRHYTHMIA  1  1/436 (0.23%)  0/464 (0.00%) 
TRICUSPID VALVE INCOMPETENCE  1  3/436 (0.69%)  0/464 (0.00%) 
VENTRICULAR DYSFUNCTION  1  1/436 (0.23%)  0/464 (0.00%) 
Congenital, familial and genetic disorders     
ATRIAL SEPTAL DEFECT  1  0/436 (0.00%)  2/464 (0.43%) 
COARCTATION OF THE AORTA  1  2/436 (0.46%)  1/464 (0.22%) 
LARYNGOMALACIA  1  0/436 (0.00%)  1/464 (0.22%) 
PULMONARY ARTERY STENOSIS CONGENITAL  1  0/436 (0.00%)  1/464 (0.22%) 
PYLORIC STENOSIS  1  1/436 (0.23%)  1/464 (0.22%) 
Ear and labyrinth disorders     
MIDDLE EAR INFLAMMATION  1  0/436 (0.00%)  1/464 (0.22%) 
Gastrointestinal disorders     
VOMITING  1  5/436 (1.15%)  5/464 (1.08%) 
DIARRHOEA  1  1/436 (0.23%)  5/464 (1.08%) 
HAEMATOCHEZIA  1  7/436 (1.61%)  2/464 (0.43%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  4/436 (0.92%)  6/464 (1.29%) 
GASTROINTESTINAL HAEMORRHAGE  1  2/436 (0.46%)  4/464 (0.86%) 
NECROTISING COLITIS  1  1/436 (0.23%)  6/464 (1.29%) 
ABDOMINAL PAIN  1  0/436 (0.00%)  2/464 (0.43%) 
ABDOMINAL DISCOMFORT  1  0/436 (0.00%)  1/464 (0.22%) 
DYSPHAGIA  1  2/436 (0.46%)  3/464 (0.65%) 
ENTEROCOLITIS HAEMORRHAGIC  1  0/436 (0.00%)  2/464 (0.43%) 
RECTAL HAEMORRHAGE  1  1/436 (0.23%)  1/464 (0.22%) 
ABDOMINAL PAIN UPPER  1  0/436 (0.00%)  1/464 (0.22%) 
ANAL FISSURE  1  1/436 (0.23%)  0/464 (0.00%) 
ENTEROCOLITIS  1  1/436 (0.23%)  0/464 (0.00%) 
GASTRITIS  1  0/436 (0.00%)  1/464 (0.22%) 
HAEMATEMESIS  1  1/436 (0.23%)  1/464 (0.22%) 
LOWER GASTROINTESTINAL HAEMORRHAGE  1  3/436 (0.69%)  1/464 (0.22%) 
POST-TUSSIVE VOMITING  1  0/436 (0.00%)  1/464 (0.22%) 
DUODENAL STENOSIS  1  1/436 (0.23%)  0/464 (0.00%) 
ENTERITIS  1  2/436 (0.46%)  0/464 (0.00%) 
INGUINAL HERNIA  1  1/436 (0.23%)  0/464 (0.00%) 
INTESTINAL OBSTRUCTION  1  1/436 (0.23%)  0/464 (0.00%) 
INTESTINAL PERFORATION  1  1/436 (0.23%)  0/464 (0.00%) 
PNEUMATOSIS INTESTINALIS  1  1/436 (0.23%)  0/464 (0.00%) 
SMALL INTESTINAL OBSTRUCTION  1  1/436 (0.23%)  0/464 (0.00%) 
General disorders     
PYREXIA  1  3/436 (0.69%)  5/464 (1.08%) 
PUNCTURE SITE HAEMORRHAGE  1  2/436 (0.46%)  1/464 (0.22%) 
CATHETER RELATED COMPLICATION  1  1/436 (0.23%)  1/464 (0.22%) 
CATHETER SITE HAEMORRHAGE  1  0/436 (0.00%)  1/464 (0.22%) 
IRRITABILITY  1  0/436 (0.00%)  1/464 (0.22%) 
CATHETER THROMBOSIS  1  1/436 (0.23%)  1/464 (0.22%) 
GENERAL PHYSICAL HEALTH DETERIORATION  1  0/436 (0.00%)  1/464 (0.22%) 
FEELING ABNORMAL  1  1/436 (0.23%)  0/464 (0.00%) 
VESSEL PUNCTURE SITE HAEMATOMA  1  1/436 (0.23%)  0/464 (0.00%) 
Hepatobiliary disorders     
ACUTE HEPATIC FAILURE  1  0/436 (0.00%)  1/464 (0.22%) 
Immune system disorders     
MILK ALLERGY  1  0/436 (0.00%)  1/464 (0.22%) 
HYPOGAMMAGLOBULINAEMIA  1  1/436 (0.23%)  0/464 (0.00%) 
Infections and infestations     
UPPER RESPIRATORY TRACT INFECTION  1  13/436 (2.98%)  11/464 (2.37%) 
GASTROENTERITIS  1  14/436 (3.21%)  24/464 (5.17%) 
PNEUMONIA  1  9/436 (2.06%)  21/464 (4.53%) 
BRONCHIOLITIS  1  12/436 (2.75%)  15/464 (3.23%) 
URINARY TRACT INFECTION  1  6/436 (1.38%)  6/464 (1.29%) 
VIRAL INFECTION  1  6/436 (1.38%)  7/464 (1.51%) 
BRONCHITIS  1  1/436 (0.23%)  4/464 (0.86%) 
LOWER RESPIRATORY TRACT INFECTION  1  2/436 (0.46%)  3/464 (0.65%) 
POSTOPERATIVE WOUND INFECTION  1  2/436 (0.46%)  7/464 (1.51%) 
WOUND INFECTION  1  2/436 (0.46%)  3/464 (0.65%) 
INFLUENZA  1  5/436 (1.15%)  6/464 (1.29%) 
GASTROENTERITIS VIRAL  1  4/436 (0.92%)  5/464 (1.08%) 
RESPIRATORY TRACT INFECTION  1  3/436 (0.69%)  3/464 (0.65%) 
SEPSIS  1  4/436 (0.92%)  8/464 (1.72%) 
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  1/436 (0.23%)  1/464 (0.22%) 
EAR INFECTION  1  0/436 (0.00%)  1/464 (0.22%) 
BRONCHOPNEUMONIA  1  4/436 (0.92%)  4/464 (0.86%) 
OTITIS MEDIA  1  1/436 (0.23%)  1/464 (0.22%) 
PULMONARY SEPSIS  1  3/436 (0.69%)  5/464 (1.08%) 
RESPIRATORY TRACT INFECTION VIRAL  1  0/436 (0.00%)  3/464 (0.65%) 
ENDOCARDITIS  1  1/436 (0.23%)  4/464 (0.86%) 
LOWER RESPIRATORY TRACT INFECTION VIRAL  1  0/436 (0.00%)  2/464 (0.43%) 
RESPIRATORY SYNCYTIAL VIRUS INFECTION  1  3/436 (0.69%)  4/464 (0.86%) 
SKIN INFECTION  1  0/436 (0.00%)  2/464 (0.43%) 
STAPHYLOCOCCAL SEPSIS  1  1/436 (0.23%)  4/464 (0.86%) 
LUNG INFECTION  1  2/436 (0.46%)  3/464 (0.65%) 
NOSOCOMIAL INFECTION  1  0/436 (0.00%)  2/464 (0.43%) 
RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLITIS  1  1/436 (0.23%)  2/464 (0.43%) 
RHINITIS  1  0/436 (0.00%)  1/464 (0.22%) 
BRONCHITIS BACTERIAL  1  0/436 (0.00%)  1/464 (0.22%) 
BRONCHITIS VIRAL  1  0/436 (0.00%)  1/464 (0.22%) 
CLOSTRIDIUM DIFFICILE COLITIS  1  1/436 (0.23%)  2/464 (0.43%) 
ENTEROCOCCAL BACTERAEMIA  1  2/436 (0.46%)  2/464 (0.43%) 
FUNGAL SEPSIS  1  0/436 (0.00%)  2/464 (0.43%) 
GASTROENTERITIS ADENOVIRUS  1  1/436 (0.23%)  1/464 (0.22%) 
GASTROENTERITIS ROTAVIRUS  1  3/436 (0.69%)  2/464 (0.43%) 
LARYNGITIS  1  0/436 (0.00%)  1/464 (0.22%) 
PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL  1  0/436 (0.00%)  2/464 (0.43%) 
POST PROCEDURAL INFECTION  1  1/436 (0.23%)  2/464 (0.43%) 
PYELONEPHRITIS  1  2/436 (0.46%)  2/464 (0.43%) 
ROTAVIRUS INFECTION  1  1/436 (0.23%)  1/464 (0.22%) 
SEPTIC SHOCK  1  0/436 (0.00%)  2/464 (0.43%) 
UROSEPSIS  1  1/436 (0.23%)  2/464 (0.43%) 
VIRAL RASH  1  0/436 (0.00%)  2/464 (0.43%) 
ABDOMINAL SEPSIS  1  0/436 (0.00%)  1/464 (0.22%) 
BACTERIAL INFECTION  1  0/436 (0.00%)  1/464 (0.22%) 
BACTERIAL SEPSIS  1  2/436 (0.46%)  0/464 (0.00%) 
CATHETER SEPSIS  1  4/436 (0.92%)  1/464 (0.22%) 
CELLULITIS  1  0/436 (0.00%)  1/464 (0.22%) 
ENTEROBACTER SEPSIS  1  1/436 (0.23%)  1/464 (0.22%) 
ENTEROCOCCAL INFECTION  1  1/436 (0.23%)  0/464 (0.00%) 
ESCHERICHIA SEPSIS  1  0/436 (0.00%)  1/464 (0.22%) 
ESCHERICHIA URINARY TRACT INFECTION  1  0/436 (0.00%)  1/464 (0.22%) 
HAEMOPHILUS INFECTION  1  0/436 (0.00%)  1/464 (0.22%) 
IMPETIGO  1  0/436 (0.00%)  1/464 (0.22%) 
INCISION SITE INFECTION  1  2/436 (0.46%)  1/464 (0.22%) 
KLEBSIELLA BACTERAEMIA  1  0/436 (0.00%)  1/464 (0.22%) 
LOBAR PNEUMONIA  1  1/436 (0.23%)  0/464 (0.00%) 
MEDIASTINAL ABSCESS  1  0/436 (0.00%)  1/464 (0.22%) 
MENINGITIS PNEUMOCOCCAL  1  1/436 (0.23%)  1/464 (0.22%) 
PARAINFLUENZAE VIRUS INFECTION  1  1/436 (0.23%)  0/464 (0.00%) 
PNEUMONIA BACTERIAL  1  0/436 (0.00%)  1/464 (0.22%) 
PNEUMONIA ESCHERICHIA  1  0/436 (0.00%)  1/464 (0.22%) 
PNEUMONIA VIRAL  1  0/436 (0.00%)  1/464 (0.22%) 
PSEUDOMONAL SEPSIS  1  1/436 (0.23%)  0/464 (0.00%) 
SEPSIS SYNDROME  1  0/436 (0.00%)  1/464 (0.22%) 
STAPHYLOCOCCAL BACTERAEMIA  1  0/436 (0.00%)  1/464 (0.22%) 
STREPTOCOCCAL SEPSIS  1  0/436 (0.00%)  1/464 (0.22%) 
ADENOVIRUS INFECTION  1  1/436 (0.23%)  0/464 (0.00%) 
CANDIDA SEPSIS  1  1/436 (0.23%)  0/464 (0.00%) 
ENTEROCOCCAL SEPSIS  1  1/436 (0.23%)  0/464 (0.00%) 
GASTROENTERITIS CALICIVIRAL  1  1/436 (0.23%)  0/464 (0.00%) 
GASTROINTESTINAL INFECTION  1  1/436 (0.23%)  0/464 (0.00%) 
KLEBSIELLA SEPSIS  1  1/436 (0.23%)  0/464 (0.00%) 
LOCALISED INFECTION  1  1/436 (0.23%)  0/464 (0.00%) 
MEDIASTINITIS  1  3/436 (0.69%)  0/464 (0.00%) 
MENINGITIS ASEPTIC  1  1/436 (0.23%)  0/464 (0.00%) 
OTITIS MEDIA ACUTE  1  2/436 (0.46%)  0/464 (0.00%) 
PERITONITIS BACTERIAL  1  1/436 (0.23%)  0/464 (0.00%) 
PNEUMOCOCCAL SEPSIS  1  1/436 (0.23%)  0/464 (0.00%) 
PNEUMONIA INFLUENZAL  1  1/436 (0.23%)  0/464 (0.00%) 
PNEUMONIA PNEUMOCOCCAL  1  2/436 (0.46%)  0/464 (0.00%) 
POST PROCEDURAL CELLULITIS  1  1/436 (0.23%)  0/464 (0.00%) 
PYELONEPHRITIS ACUTE  1  1/436 (0.23%)  0/464 (0.00%) 
RESPIRATORY TRACT INFECTION BACTERIAL  1  1/436 (0.23%)  0/464 (0.00%) 
VIRAL DIARRHOEA  1  1/436 (0.23%)  0/464 (0.00%) 
WOUND ABSCESS  1  2/436 (0.46%)  0/464 (0.00%) 
WOUND SEPSIS  1  1/436 (0.23%)  0/464 (0.00%) 
Injury, poisoning and procedural complications     
POST PROCEDURAL HAEMORRHAGE  1  4/436 (0.92%)  8/464 (1.72%) 
ACCIDENTAL OVERDOSE  1  2/436 (0.46%)  3/464 (0.65%) 
OPERATIVE HAEMORRHAGE  1  3/436 (0.69%)  3/464 (0.65%) 
POSTOPERATIVE FEVER  1  0/436 (0.00%)  1/464 (0.22%) 
SHUNT STENOSIS  1  2/436 (0.46%)  2/464 (0.43%) 
FALL  1  0/436 (0.00%)  1/464 (0.22%) 
SUTURE RELATED COMPLICATION  1  0/436 (0.00%)  1/464 (0.22%) 
FEEDING TUBE COMPLICATION  1  0/436 (0.00%)  1/464 (0.22%) 
PNEUMOTHORAX TRAUMATIC  1  0/436 (0.00%)  1/464 (0.22%) 
POST PROCEDURAL HAEMATOMA  1  0/436 (0.00%)  1/464 (0.22%) 
POST VACCINATION SYNDROME  1  0/436 (0.00%)  1/464 (0.22%) 
PROCEDURAL SITE REACTION  1  1/436 (0.23%)  1/464 (0.22%) 
SHUNT BLOOD FLOW EXCESSIVE  1  0/436 (0.00%)  1/464 (0.22%) 
WOUND DEHISCENCE  1  1/436 (0.23%)  0/464 (0.00%) 
DEVICE BREAKAGE  1  1/436 (0.23%)  0/464 (0.00%) 
DRUG TOXICITY  1  1/436 (0.23%)  0/464 (0.00%) 
GRAFT THROMBOSIS  1  1/436 (0.23%)  0/464 (0.00%) 
INCISIONAL HERNIA  1  1/436 (0.23%)  0/464 (0.00%) 
POSTOPERATIVE RESPIRATORY DISTRESS  1  1/436 (0.23%)  0/464 (0.00%) 
POSTOPERATIVE WOUND COMPLICATION  1  1/436 (0.23%)  0/464 (0.00%) 
PROCEDURAL COMPLICATION  1  2/436 (0.46%)  0/464 (0.00%) 
SEROMA  1  1/436 (0.23%)  0/464 (0.00%) 
SHUNT MALFUNCTION  1  3/436 (0.69%)  0/464 (0.00%) 
SHUNT OCCLUSION  1  1/436 (0.23%)  0/464 (0.00%) 
SKULL FRACTURE  1  1/436 (0.23%)  0/464 (0.00%) 
SUTURE RUPTURE  1  1/436 (0.23%)  0/464 (0.00%) 
VASCULAR PSEUDOANEURYSM  1  1/436 (0.23%)  0/464 (0.00%) 
Investigations     
OXYGEN SATURATION DECREASED  1  10/436 (2.29%)  11/464 (2.37%) 
BLOOD URINE PRESENT  1  1/436 (0.23%)  0/464 (0.00%) 
PULMONARY ARTERIAL PRESSURE DECREASED  1  0/436 (0.00%)  1/464 (0.22%) 
WEIGHT INCREASED  1  0/436 (0.00%)  1/464 (0.22%) 
ASPIRATION BRONCHIAL  1  1/436 (0.23%)  0/464 (0.00%) 
OXYGEN SATURATION INCREASED  1  1/436 (0.23%)  0/464 (0.00%) 
PLATELET COUNT DECREASED  1  1/436 (0.23%)  0/464 (0.00%) 
PULMONARY ARTERIAL PRESSURE INCREASED  1  1/436 (0.23%)  0/464 (0.00%) 
Metabolism and nutrition disorders     
DEHYDRATION  1  1/436 (0.23%)  6/464 (1.29%) 
FEEDING DISORDER OF INFANCY OR EARLY CHILDHOOD  1  5/436 (1.15%)  2/464 (0.43%) 
WEIGHT GAIN POOR  1  3/436 (0.69%)  0/464 (0.00%) 
FAILURE TO THRIVE  1  6/436 (1.38%)  3/464 (0.65%) 
FOOD INTOLERANCE  1  3/436 (0.69%)  1/464 (0.22%) 
HYPERKALAEMIA  1  0/436 (0.00%)  1/464 (0.22%) 
HYPOGLYCAEMIA  1  1/436 (0.23%)  1/464 (0.22%) 
MALNUTRITION  1  0/436 (0.00%)  1/464 (0.22%) 
METABOLIC ACIDOSIS  1  2/436 (0.46%)  2/464 (0.43%) 
HYPOCALCAEMIA  1  0/436 (0.00%)  1/464 (0.22%) 
HYPONATRAEMIA  1  0/436 (0.00%)  1/464 (0.22%) 
HYPOPROTEINAEMIA  1  0/436 (0.00%)  1/464 (0.22%) 
HYPOGLYCAEMIC SEIZURE  1  1/436 (0.23%)  0/464 (0.00%) 
Nervous system disorders     
CONVULSION  1  2/436 (0.46%)  3/464 (0.65%) 
PARTIAL SEIZURES  1  0/436 (0.00%)  3/464 (0.65%) 
ISCHAEMIC STROKE  1  0/436 (0.00%)  3/464 (0.65%) 
VOCAL CORD PARALYSIS  1  0/436 (0.00%)  1/464 (0.22%) 
CEREBRAL INFARCTION  1  0/436 (0.00%)  2/464 (0.43%) 
CEREBRAL ISCHAEMIA  1  0/436 (0.00%)  2/464 (0.43%) 
LETHARGY  1  0/436 (0.00%)  2/464 (0.43%) 
POOR SUCKING REFLEX  1  0/436 (0.00%)  1/464 (0.22%) 
VOCAL CORD PARESIS  1  0/436 (0.00%)  1/464 (0.22%) 
CLONIC CONVULSION  1  0/436 (0.00%)  1/464 (0.22%) 
DYSKINESIA  1  0/436 (0.00%)  1/464 (0.22%) 
EMBOLIC STROKE  1  0/436 (0.00%)  1/464 (0.22%) 
ENCEPHALITIS  1  0/436 (0.00%)  1/464 (0.22%) 
HYPOGLYCAEMIC ENCEPHALOPATHY  1  0/436 (0.00%)  1/464 (0.22%) 
ISCHAEMIC CEREBRAL INFARCTION  1  0/436 (0.00%)  1/464 (0.22%) 
PHRENIC NERVE PARALYSIS  1  0/436 (0.00%)  1/464 (0.22%) 
SUBARACHNOID HAEMORRHAGE NEONATAL  1  0/436 (0.00%)  1/464 (0.22%) 
CONVULSIONS LOCAL  1  1/436 (0.23%)  0/464 (0.00%) 
FEBRILE CONVULSION  1  1/436 (0.23%)  0/464 (0.00%) 
HYDROCEPHALUS  1  1/436 (0.23%)  0/464 (0.00%) 
Psychiatric disorders     
AGITATION  1  1/436 (0.23%)  1/464 (0.22%) 
Renal and urinary disorders     
RENAL FAILURE  1  1/436 (0.23%)  2/464 (0.43%) 
HAEMATURIA  1  0/436 (0.00%)  1/464 (0.22%) 
ACUTE PRERENAL FAILURE  1  1/436 (0.23%)  0/464 (0.00%) 
BLADDER PROLAPSE  1  1/436 (0.23%)  0/464 (0.00%) 
VESICOURETERIC REFLUX  1  1/436 (0.23%)  0/464 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
HYPOXIA  1  11/436 (2.52%)  14/464 (3.02%) 
COUGH  1  1/436 (0.23%)  1/464 (0.22%) 
RESPIRATORY DISTRESS  1  3/436 (0.69%)  5/464 (1.08%) 
PULMONARY ARTERY STENOSIS  1  2/436 (0.46%)  3/464 (0.65%) 
RESPIRATORY FAILURE  1  4/436 (0.92%)  5/464 (1.08%) 
PULMONARY HAEMORRHAGE  1  2/436 (0.46%)  3/464 (0.65%) 
DIAPHRAGMATIC PARALYSIS  1  2/436 (0.46%)  1/464 (0.22%) 
PLEURAL EFFUSION  1  1/436 (0.23%)  0/464 (0.00%) 
PNEUMOTHORAX  1  2/436 (0.46%)  2/464 (0.43%) 
STRIDOR  1  1/436 (0.23%)  0/464 (0.00%) 
ATELECTASIS  1  1/436 (0.23%)  2/464 (0.43%) 
DYSPNOEA  1  1/436 (0.23%)  2/464 (0.43%) 
LARYNGEAL STENOSIS  1  1/436 (0.23%)  1/464 (0.22%) 
OBSTRUCTIVE AIRWAYS DISORDER  1  0/436 (0.00%)  1/464 (0.22%) 
PNEUMONIA ASPIRATION  1  0/436 (0.00%)  1/464 (0.22%) 
PULMONARY HYPERTENSION  1  2/436 (0.46%)  2/464 (0.43%) 
PULMONARY OEDEMA  1  0/436 (0.00%)  1/464 (0.22%) 
PULMONARY VEIN STENOSIS  1  1/436 (0.23%)  1/464 (0.22%) 
TACHYPNOEA  1  2/436 (0.46%)  1/464 (0.22%) 
UPPER RESPIRATORY TRACT CONGESTION  1  0/436 (0.00%)  1/464 (0.22%) 
ACUTE RESPIRATORY DISTRESS SYNDROME  1  0/436 (0.00%)  1/464 (0.22%) 
ASPIRATION  1  2/436 (0.46%)  1/464 (0.22%) 
BRONCHOSTENOSIS  1  0/436 (0.00%)  1/464 (0.22%) 
CHYLOTHORAX  1  1/436 (0.23%)  1/464 (0.22%) 
DYSPNOEA EXERTIONAL  1  0/436 (0.00%)  1/464 (0.22%) 
LARYNGEAL OEDEMA  1  1/436 (0.23%)  0/464 (0.00%) 
PULMONARY VEIN OCCLUSION  1  0/436 (0.00%)  1/464 (0.22%) 
RESPIRATORY ARREST  1  1/436 (0.23%)  1/464 (0.22%) 
RESPIRATORY FATIGUE  1  0/436 (0.00%)  1/464 (0.22%) 
TRACHEOMALACIA  1  0/436 (0.00%)  1/464 (0.22%) 
APNOEA  1  1/436 (0.23%)  0/464 (0.00%) 
HAEMOPTYSIS  1  1/436 (0.23%)  0/464 (0.00%) 
HAEMOTHORAX  1  1/436 (0.23%)  0/464 (0.00%) 
MEDIASTINAL HAEMATOMA  1  1/436 (0.23%)  0/464 (0.00%) 
MEDIASTINAL HAEMORRHAGE  1  1/436 (0.23%)  0/464 (0.00%) 
PULMONARY CONGESTION  1  1/436 (0.23%)  0/464 (0.00%) 
PULMONARY EMBOLISM  1  1/436 (0.23%)  0/464 (0.00%) 
TRACHEAL STENOSIS  1  1/436 (0.23%)  0/464 (0.00%) 
VOCAL CORD THICKENING  1  1/436 (0.23%)  0/464 (0.00%) 
Skin and subcutaneous tissue disorders     
DERMATITIS DIAPER  1  0/436 (0.00%)  1/464 (0.22%) 
DERMATITIS ALLERGIC  1  0/436 (0.00%)  1/464 (0.22%) 
RASH PAPULAR  1  0/436 (0.00%)  1/464 (0.22%) 
SUBCUTANEOUS EMPHYSEMA  1  0/436 (0.00%)  1/464 (0.22%) 
Surgical and medical procedures     
ANORECTAL OPERATION  1  0/436 (0.00%)  1/464 (0.22%) 
CARDIOVASCULAR EVENT PROPHYLAXIS  1  0/436 (0.00%)  1/464 (0.22%) 
URETERONEOCYSTOSTOMY  1  0/436 (0.00%)  1/464 (0.22%) 
Vascular disorders     
AORTIC STENOSIS  1  2/436 (0.46%)  2/464 (0.43%) 
VENA CAVA THROMBOSIS  1  1/436 (0.23%)  2/464 (0.43%) 
CIRCULATORY COLLAPSE  1  0/436 (0.00%)  1/464 (0.22%) 
HYPOVOLAEMIC SHOCK  1  1/436 (0.23%)  1/464 (0.22%) 
PERIPHERAL ISCHAEMIA  1  0/436 (0.00%)  1/464 (0.22%) 
SHOCK  1  0/436 (0.00%)  1/464 (0.22%) 
VASCULAR STENOSIS  1  0/436 (0.00%)  1/464 (0.22%) 
VENOUS THROMBOSIS  1  1/436 (0.23%)  0/464 (0.00%) 
EMBOLISM  1  1/436 (0.23%)  0/464 (0.00%) 
HYPOTENSION  1  2/436 (0.46%)  0/464 (0.00%) 
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE  1  1/436 (0.23%)  0/464 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Clopidogrel 0.2mg/kg/Day
Affected / at Risk (%) Affected / at Risk (%)
Total   96/436 (22.02%)   107/464 (23.06%) 
Gastrointestinal disorders     
VOMITING  1  18/436 (4.13%)  32/464 (6.90%) 
DIARRHOEA  1  20/436 (4.59%)  24/464 (5.17%) 
Infections and infestations     
UPPER RESPIRATORY TRACT INFECTION  1  53/436 (12.16%)  60/464 (12.93%) 
NASOPHARYNGITIS  1  24/436 (5.50%)  21/464 (4.53%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 12.1
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.
If no publication has occurred within 12 months after trial completion, the Investigator can publish the results. Prior to publication, the sponsor shall review the manuscript and can request changes, provided they do not jeopardize the accuracy and/or the scientific value of the publication. The approval is given in writing by the sponsor, not exceeding 90 days.
Results Point of Contact
Name/Title: Trial Transparency Team
Organization: sanofi-aventis
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00396877     History of Changes
Other Study ID Numbers: EFC5314
2006-000946-38 ( EudraCT Number )
First Submitted: November 7, 2006
First Posted: November 8, 2006
Results First Submitted: February 15, 2011
Results First Posted: March 11, 2011
Last Update Posted: October 24, 2014