NCT00396877: CLARINET

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

Completed Phase 3 Results posted Last updated 14 October 2014

What this trial tests

Phase 3 trial testing Clopidogrel (SR25990) in Heart Defects, Congenital in 906 participants. Completed in 1 February 2010.

Timeline

1 November 2006

Primary endpoint
1 February 2010

1 February 2010

Quick facts

Lead sponsor	Sanofi
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	906
Start date	1 November 2006
Primary completion	1 February 2010
Estimated completion	1 February 2010
Sites	31 locations across United States, Argentina, Belgium, Brazil, Canada, China, Denmark, Egypt

Drugs / interventions tested

• Clopidogrel (SR25990) — full drug profile →
• placebo

Conditions studied

• Heart Defects, Congenital — all drugs for Heart Defects, Congenital →

Sponsor

Sanofi — full company profile →

Who can join

Under 92 Days, any sex, with Heart Defects, Congenital. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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 e

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The molecular mechanisms of cardiac development and related diseases.
   Li Y, Du J, Deng S, Liu B, et al · · 2024 · cited 53× · PMID 39715759 · DOI 10.1038/s41392-024-02069-8
2. Clopidogrel in infants with systemic-to-pulmonary-artery shunts.
   Wessel DL, Berger F, Li JS, Dähnert I, et al · · 2013 · cited 47× · PMID 23782178 · DOI 10.1056/nejmoa1114588
3. Hypoglycemia as a potential risk for patients taking clopidogrel: A systematic review and meta-analysis.
   Chen S, Qiang J, Zhang Y, Zhao B, et al · · 2023 · cited 4× · PMID 36926026 · DOI 10.3389/fendo.2023.1091933