Heart Defects, CongenitalPhase 3CLARINETNCT00396877
Efficacy And Safety Of Clopidogrel In Neonates /Infants With Systemic To Pulmonary Artery Shunt Palliation
A Phase 3 study testing Clopidogrel (SR25990) in people with Heart Defects, Congenital, run by Sanofi at 31 sites in 31 countries.
Trial summary
Contemporary management of cyanotic congenital heart disease includes three stages of surgery. Incidence of shunt thrombosis and death between the two first stages of palliation remains important. Read more about this study
- Who is it for?
- Ages Up to 92 days
- Conditions the study is for
- Heart Defects, Congenital
- What is being tested?
- Clopidogrel (SR25990)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 906 participants
- Where
- 31 sitesin 31 countries
- Study dates
- Nov 2006to Feb 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 92 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Cyanotic congenital heart disease treated by any palliative systemic-to-pulmonary artery shunt.
Who cannot join
- Active bleeding or increase risk of bleeding,
- Allergy to 2 or more classes of drug,
- Unable to receive drug orally or enterically,
- Current clinically significant or persistent thrombocytopenia, neutropenia, severe hepatic or renal failure.
Trial locations and contacts
31 sites in 31 countries.
31 sites in 31 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 94609
United Kingdom1 site
Sanofi-Aventis Admnistrative Office
Guildford Surrey
About this study
Official title: International Randomized Double Blind Study Evaluating the Efficacy and the Safety of Clopidogrel 0.2 mg/kg Once Daily Versus Placebo in Neonates and Infants With Cyanotic Congenital Heart Disease Palliated With Systemic to Pulmonary Artery Shunt
Contemporary management of cyanotic congenital heart disease includes three stages of surgery. Incidence of shunt thrombosis and death between the two first stages of palliation remains important.
The primary objective of the study is to evaluate the efficacy of Clopidogrel 0.2 mg/kg/day for the reduction of all cause mortality and shunt related morbidity in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt (e.g. modified Blalock Taussig Shunt [BTS]).
The secondary objective was to assess the safety of Clopidogrel in the study population.
Read the detailed description
In this event-driven study, participants were to be randomized and treated as soon as possible after shunt placement. They were then to be treated and followed until the primary endpoint criteria was reached i.e. (shunt thrombosis, the next surgical procedure for correction of the congenital heart disease or death) or one year of age or the common study-end-date, which ever came first.
The common study-en-date was defined as the date when it was projected that 172 participants would have reached the primary endpoint criteria.
- Conditions
- Heart Defects, Congenital
- Being tested
- Clopidogrel (SR25990), placebo
- Keywords
- cyanotic congenital heart disease, shunt palliation, thrombosis, clopidogrel
- Medical subject headings
- Heart Defects, Congenital, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clopidogrel (SR25990)Drug
Also called Plavix
Form: reconstituted solution using Clopidogrel powder
Route: oral or enteric
Frequency: once daily
Dose: daily dose adjusted for weight
placeboDrug
Form: reconstituted solution using matching placebo powder
Route: oral or enteric
Frequency: once daily
Dose: daily dose adjusted for weight
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
| Clopidogrel 0.2 mg/kg/day | Experimental | Not described Receives: Drug: Clopidogrel (SR25990) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reaching Primary Endpoint Criteria (First Occurrence of Death / Shunt Thrombosis / Cardiac Procedure < 120 Days Considered of Thrombotic Nature)
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.
Measured: Median follow-up of 5.8 months (up to a maximum of 12 months after randomization)
Secondary outcomes (2)
Number of Participants With Bleeding Events
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.
Measured: From randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever comes first
Number of Participants According to Bleeding Type/Etiology
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.
Measured: From randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 906 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- International Clinical Development Clinical Study Director, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396877
- Sponsor's protocol ID
- EFC5314
- Other IDs
- 2006-000946-38
- Acronym
- CLARINET
- Status last verified
- Oct 2014
- First submitted
- 7 Nov 2006
- Last updated
- 24 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wessel DL, Berger F, Li JS, Dahnert I, Rakhit A, Fontecave S, Newburger JW; CLARINET Investigators. Clopidogrel in infants with systemic-to-pulmonary-artery shunts. N Engl J Med. 2013 Jun 20;368(25):2377-84. doi: 10.1056/NEJMoa1114588.
PubMed 23782178
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Randomized Double Blind Study Evaluating the Efficacy and the Safety of Clopidogrel 0.2 mg/kg Once Daily Versus Placebo in Neonates and Infants With Cyanotic Congenital Heart Disease Palliated With Systemic to Pulmonary Artery Shunt
- ClinicalTrials.gov ID
- NCT00396877
- Acronym / sponsor ID
- CLARINET / EFC5314
- Conditions
- Heart Defects, Congenital
- Keywords
- cyanotic congenital heart disease, shunt palliation, thrombosis, clopidogrel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 906 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Nov 2006
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 8 Nov 2006 (estimated)
- Results
- Posted 11 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Contemporary management of cyanotic congenital heart disease includes three stages of surgery. Incidence of shunt thrombosis and death between the two first stages of palliation remains important.
The primary objective of the study is to evaluate the efficacy of Clopidogrel 0.2 mg/kg/day for the reduction of all cause mortality and shunt related morbidity in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt (e.g. modified Blalock Taussig Shunt [BTS]).
The secondary objective was to assess the safety of Clopidogrel in the study population.
Detailed description
In this event-driven study, participants were to be randomized and treated as soon as possible after shunt placement. They were then to be treated and followed until the primary endpoint criteria was reached i.e. (shunt thrombosis, the next surgical procedure for correction of the congenital heart disease or death) or one year of age or the common study-end-date, which ever came first.
The common study-en-date was defined as the date when it was projected that 172 participants would have reached the primary endpoint criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placebo |
| Clopidogrel 0.2 mg/kg/day | Experimental | Drug: Clopidogrel (SR25990) |
Who may qualify
- Ages
- Up to 92 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Cyanotic congenital heart disease treated by any palliative systemic-to-pulmonary artery shunt.
Key exclusion criteria (4 listed)
- Active bleeding or increase risk of bleeding,
- Allergy to 2 or more classes of drug,
- Unable to receive drug orally or enterically,
- Current clinically significant or persistent thrombocytopenia, neutropenia, severe hepatic or renal failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clopidogrel (SR25990)Also: PlavixForm: reconstituted solution using Clopidogrel powder Route: oral or enteric Frequency: once daily Dose: daily dose adjusted for weight | Drug | Clopidogrel 0.2 mg/kg/day |
| placeboForm: reconstituted solution using matching placebo powder Route: oral or enteric Frequency: once daily Dose: daily dose adjusted for weight | Drug | Placebo |
Primary outcome
Number of Participants Reaching Primary Endpoint Criteria (First Occurrence of Death / Shunt Thrombosis / Cardiac Procedure < 120 Days Considered of Thrombotic Nature)
Time frame: Median follow-up of 5.8 months (up to a maximum of 12 months after randomization)
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.
2 secondary outcomes
Number of Participants With Bleeding Events
Time frame: From randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever comes first
Number of Participants According to Bleeding Type/Etiology
Time frame: From randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever comes first
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23782178Wessel DL, Berger F, Li JS, Dahnert I, Rakhit A, Fontecave S, Newburger JW; CLARINET Investigators. Clopidogrel in infants with systemic-to-pulmonary-artery shunts. N Engl J Med. 2013 Jun 20;368(25):2377-84. doi: 10.1056/NEJMoa1114588.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
International Clinical Development Clinical Study Director study director
Sanofi
31 sites in 31 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clopidogrel (SR25990) in people with Heart Defects, Congenital, run by Sanofi at 31 sites in 31 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Argentina, Belgium, Brazil, Canada and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reaching Primary Endpoint Criteria (First Occurrence of Death / Shunt Thrombosis / Cardiac Procedure < 120 Days Considered of Thrombotic Nature) (time frame: Median follow-up of 5.8 months (up to a maximum of 12 months after randomization)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00396877, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2014.