Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT01266694
Status:
COMPLETED
Last Update Posted:
2014-01-14
First Post:
2010-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cochicine Treatment for Post- Operative Pericardial Effusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010490', 'term': 'Pericardial Effusion'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003078', 'term': 'Colchicine'}], 'ancestors': [{'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 199}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-13', 'studyFirstSubmitDate': '2010-12-23', 'studyFirstSubmitQcDate': '2010-12-23', 'lastUpdatePostDateStruct': {'date': '2014-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in effusion grade', 'timeFrame': '14 days'}], 'secondaryOutcomes': [{'measure': 'frequency of late cardiac tamponade', 'timeFrame': '14 days'}, {'measure': 'number of patients with at least a one-grade decrease in the effusion', 'timeFrame': '14 days'}, {'measure': 'mean change in the width of the effusion measured in millimeters', 'timeFrame': '14 days'}, {'measure': 'evolution of prespecified subgroups', 'timeFrame': '14 days', 'description': '* patients with inflammatory syndrom : crp \\> 30 mg/l\n* patients receiving an anticoagulant\n* patients with a post pericardiotomy syndrom'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pericardial effusion', 'Cardiac surgery', 'Tamponade', 'colchicine'], 'conditions': ['Pericardial Effusion']}, 'referencesModule': {'references': [{'pmid': '26076938', 'type': 'DERIVED', 'citation': 'Meurin P, Lelay-Kubas S, Pierre B, Pereira H, Pavy B, Iliou MC, Bussiere JL, Weber H, Beugin JP, Farrokhi T, Bellemain-Appaix A, Briota L, Tabet JY; French Society of Cardiology. Colchicine for postoperative pericardial effusion: a multicentre, double-blind, randomised controlled trial. Heart. 2015 Nov;101(21):1711-6. doi: 10.1136/heartjnl-2015-307827. Epub 2015 Jun 15.'}]}, 'descriptionModule': {'briefSummary': 'Background: The incidence of asymptomatic pericardial effusion is high after cardiac surgery.\n\nObjective: To assess whether colchicine is effective in reducing post operative pericardial effusion volume.\n\nDesign: Multicenter, randomized, double-blind, placebo-controlled study. Intervention : colchicine 1mg vs placebo, once daily for 14 days Setting :10 post operative cardiac rehabilitation centers. Patients: 200 patients at high risk of tamponade because of moderate to large persistent pericardial effusion (grade 2, 3 or 4 on a scale of 0 to 4 measured by echocardiography) more than 7 days after cardiac surgery.\n\nMeasurements: The main end point will be change in effusion grade after 14 days of treatment. Secondary endpoints include frequency of late cardiac tamponade.', 'detailedDescription': 'Clinically insignificant pericardial effusion is common after heart surgery with an incidence of 50 % to 85 % a few days after surgery Cardiac tamponade occurs in about 1-2 % of patients who undergo cardiac surgery and may develop slowly without clear-cut clinical signs. Most tamponade occurs more than 7 days after surgery which is a concern because, at that time, patients often have already been discharged from the hospital.\n\nNo study has ever shown the efficacy any drug for this condition.In particular, we published a study demonstrating the absence of efficacy of a non steroidal anti inflammatory drug (Meurin P, Tabet JY, Thabut G, et al.French Society of Cardiology. Nonsteroidal anti-inflammatory drug treatment for postoperative pericardial effusion: a multicenter randomized, double-blind trial. Ann Intern Med. 2010 Feb2;152(3):137-43) Cochicine is widely used to treat inflammatory pericarditis ; is it efficient to treat post operative pericardial effusions ? this is the question we want to answer to.\n\nDesign: Multicenter, randomized, double-blind, placebo-controlled study. Intervention : colchicine 1mg vs placebo, once daily for 14 days Setting :10 post operative cardiac rehabilitation centers. Patients: 200 patients at high risk of tamponade because of moderate to large persistent pericardial effusion (grade 2, 3 or 4 on a scale of 0 to 4 measured by echocardiography) more than 7 days after cardiac surgery.\n\nMeasurements: The main end point will be change in effusion grade after 14 days of treatment. Secondary endpoints include frequency of late cardiac tamponade.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with recent cardiac surgery\n* admitted for cardiac rehabilitation\n* pericardial effusion \\> grade 2 (corresponds to a loculated effusion \\> 10 millimeters or a circumferential effusion of any size)on the first trans thoracic echocardiography performed more than 7 days after surgery\n\nExclusion Criteria:\n\n* patients who do not give written consent to participate\n* pregnancy\n* colchicine allergy;\n* renal failure, which we define as a serum creatinine level \\> 250micromol/l or clairance \\< 30 ml/mn\n* heart transplantation,or correction of congenital heart anomalies cardiac surgery more than 30 days before their first trans thoracic echocardiography pericardial effusion that requires immediate drainage.'}, 'identificationModule': {'nctId': 'NCT01266694', 'acronym': 'POPE2', 'briefTitle': 'Cochicine Treatment for Post- Operative Pericardial Effusion', 'organization': {'class': 'OTHER', 'fullName': 'French Cardiology Society'}, 'officialTitle': 'Cochicine Treatment for Post- Operative Pericardial Effusion: The POPE 2 Study A Multicenter, Double-blind, Randomized Trial', 'orgStudyIdInfo': {'id': '2010-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cochicine', 'description': 'Colchicine arm: patient receiving 1 mg per day for 14 days', 'interventionNames': ['Drug: Colchicines']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'patients placebo controlled', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Colchicines', 'type': 'DRUG', 'description': 'oral form, 1 mg, once a day during 14 days', 'armGroupLabels': ['Cochicine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral form, placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37510', 'city': 'Ballan-Miré', 'country': 'France', 'facility': 'Bois Gibert', 'geoPoint': {'lat': 47.34057, 'lon': 0.61466}}, {'zip': '91640', 'city': 'Briis-sous-Forges', 'country': 'France', 'facility': 'Centre Médical de Bligny', 'geoPoint': {'lat': 48.62399, 'lon': 2.12112}}, {'zip': '92320', 'city': 'Châtillon', 'country': 'France', 'facility': 'Clinique de Châtillon', 'geoPoint': {'lat': 48.8024, 'lon': 2.29346}}, {'zip': '26220', 'city': 'Dieulefit', 'country': 'France', 'facility': 'Centre Dieulefit Santé', 'geoPoint': {'lat': 44.52563, 'lon': 5.0618}}, {'zip': '92133', 'city': 'Issy-les-Moulineaux', 'country': 'France', 'facility': 'Hopital Corentin Celton', 'geoPoint': {'lat': 48.82104, 'lon': 2.27718}}, {'zip': '59160', 'city': 'Lomme', 'country': 'France', 'facility': 'Clinique de la mitterie', 'geoPoint': {'lat': 50.64358, 'lon': 2.98715}}, {'zip': '44270', 'city': 'Machecoul', 'country': 'France', 'facility': 'Centre Hospitalier Loire Vendée Océan', 'geoPoint': {'lat': 46.99336, 'lon': -1.82298}}, {'zip': '69280', 'city': "Marcy-l'Étoile", 'country': 'France', 'facility': 'Clinique Iris', 'geoPoint': {'lat': 45.78118, 'lon': 4.7062}}, {'zip': '06140', 'city': 'Vence', 'country': 'France', 'facility': 'Maison du mineur', 'geoPoint': {'lat': 43.72254, 'lon': 7.11183}}, {'zip': '77174', 'city': 'Villeneuve-Saint-Denis', 'country': 'France', 'facility': 'Clinique les Grands Près', 'geoPoint': {'lat': 48.81578, 'lon': 2.79353}}], 'overallOfficials': [{'name': 'Philippe Meurin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique Les Grands Près - Villeneuve Saint Denis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French Cardiology Society', 'class': 'OTHER'}, 'collaborators': [{'name': 'French Federation of Cardiology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}