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Clinical Trials/EUCTR2016-002956-25-IT
EUCTR2016-002956-25-IT
Active, not recruiting
Phase 1

Olevia for the prevention of atrial fibrillation post heart valve-surgery. - ND

FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE0 sites152 target enrollmentOctober 6, 2020
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ConditionsPOST-OPERATIVE ATRIAL FIBRILLATIONMedDRA version: 20.0Level: LLTClassification code 10016566Term: Fibrillation atrialSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsOMEGAIBSA2 - 1000 MG CAPSULA MOLLE 2X10 CAPSULE

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
POST-OPERATIVE ATRIAL FIBRILLATION
Sponsor
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
Enrollment
152
Status
Active, not recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 6, 2020
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE

Eligibility Criteria

Inclusion Criteria

  • •Informed consent signed before starting any procedure provided by the study;
  • •age \= 18 years;
  • •candidates for heart valve surgery;
  • •Sinus rhytm on ECG performed at pre\-hospedalization time (with or not history of atrial fibrillation).
  • •Sexual abstinence for two months for male patients.
  • •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 12
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •Treatment ongoing with Olevia (hypertriglyceridemia, post\-ischemic heart attack) at the time of enrollment;
  • •controindications to Olevia and excipiens;
  • •indication to combined heart valve surgery and coronary artery bypass surgery
  • •impaired liver function (transaminase 1,5 times the upper reference limit );
  • •impaired renal function (serum creatinine \=2\.5 mg/dl);
  • •pregnancy, breast\-feeding, women in childbearing age;
  • •blood dyscrasias (anemias with HB \<10 g/dl, myelodysplastic syndromes,myeloproliferative syndromes) thrombocytopenia.
  • •gastrointestinal inflammatory diseases;
  • •autoimmune diseases;
  • •hypersensivity to the active substance or to soya lecithin or to any of the excipients;

Outcomes

Primary Outcomes

Not specified

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