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Clinical Trials/EUCTR2006-005328-18-BE
EUCTR2006-005328-18-BE
Active, not recruiting
Phase 1

PEITHO Pulmonary EmbolIsm THrOmbolysis Study. A prospective, randomized, double-blind, placebo-controlled, international, multicentre, parallel-group comparison trial evaluating the efficacy and safety of single i.v. bolus tenecteplase plus standard anticoagulation as compared with standard anticoagulation in normotensive patients with acute pulmonary embolism and with echocardiographic (or spiral CT) and laboratory evidence of right ventricular dysfunction. - PEITHO

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)0 sites1,000 target enrollmentAugust 20, 2009
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ConditionsPatients atteints d'embolie pulmonaire de gravité intermédiaire
DrugsMétalyse

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Patients atteints d'embolie pulmonaire de gravité intermédiaire
Sponsor
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Enrollment
1000
Status
Active, not recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 20, 2009
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\-age supérieur ou égal à 18 ans
  • •\-embolie pulmonaire (1ers symptomes depuis 15 j ou moins)
  • •\-dysfonction ventriculaire droite confirmée par échographie et troponine I ou T (la nouvelle version amendée prévoit d'inclure:
  • •\-tout patient ayant une Troponine I ou T positive (Troponine I\>0\.06 ug/L ou Troponine T\>0\.01 ug/L et ce quelquesoit le test utilisé).
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •\-collapsus hémodynamique
  • •\-risque hémorrhagique connu
  • •\-administration d'agents thrombolytiques dans les 4 jours précédents l'inclusion
  • •\-hypertension incontrôlée
  • •\-systolique \>180 mmHg
  • •\-et/ou diastolique \>110 mmHg
  • •\-absence de contraception efficace pour les femmes en âge de procréer
  • •\-femmes enceintes
  • •\-troubles de la coagulation connu (la nouvelle version amendée prévoit de ne pas inclure des patients ayant un taux de plaquettes \< 100 000/mm3\)

Outcomes

Primary Outcomes

Not specified

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