Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-27 @ 2:59 PM
Study NCT ID:
NCT04023266
Status:
COMPLETED
Last Update Posted:
2022-10-06
First Post:
2019-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Randomized Controlled Trial of Intravenous N-acetyl Cysteine in STEMI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016568', 'term': 'Drugs, Generic'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-10', 'size': 381938, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-10-02T16:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The clinical outcomes assessor reading the cardiac MRI would be blinded to the study arm allotment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Investigator-initiated prospective, single-center, double- arm non-blinded randomized controlled trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-03', 'studyFirstSubmitDate': '2019-07-09', 'studyFirstSubmitQcDate': '2019-07-16', 'lastUpdatePostDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myocardial infarct size', 'timeFrame': '3-5 days after first medical contact', 'description': 'The primary clinical endpoint will be myocardial infarct size measured by late gadolinium enhancement CMR imaging at 3-5 days from first medical contact.'}, {'measure': 'Feasibility outcomes', 'timeFrame': 'Assessed at the end of the study', 'description': 'Primary feasibility outcomes would include the rate of recruitment, the number of patients undergoing cardiac MRI within the stipulated time frame, and completeness of the study data collection.'}], 'secondaryOutcomes': [{'measure': 'Myocardial salvage', 'timeFrame': '3-5 days after infarction', 'description': 'Myocardial salvage as measured by T2-weighted short tau inversion recovery on CMR assessed at 3-5 days after infarction'}, {'measure': 'Left ventricular ejection fraction', 'timeFrame': '3-5 days after infarction', 'description': 'Left ventricular ejection fraction on CMR at 3-5 days'}, {'measure': 'ST-segment elevation resolution', 'timeFrame': '90-minutes after thrombolysis', 'description': 'ST-segment elevation resolution at 90 minutes after thrombolysis as assessed by the worst lead on electrocardiogram (ECG core lab).'}, {'measure': 'TIMI frame count in infarct related artery', 'timeFrame': 'During index coronary angiogram which will be performed within 24 hours of admission', 'description': 'TIMI frame count on baseline coronary angiogram in the infarct-related artery'}, {'measure': 'Creatine kinase MB area under the curve', 'timeFrame': '24 hours after admission', 'description': 'Creatine kinase MB area under the curve through 24 hours'}, {'measure': 'Von Willebrand factor fragmentation', 'timeFrame': 'At the time of angiography, assessed up to 7 days from admission', 'description': 'The proportion of Von Willebrand factor multimers in the low, intermediate and high molecular weight form at the time of angiography'}, {'measure': 'Bleeding', 'timeFrame': 'From time of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 90 days', 'description': 'Bleeding research consortium type II, III and V bleeding; safety outcome'}, {'measure': 'Allergic reactions', 'timeFrame': 'From time of randomization, upto 48 hours', 'description': 'Allergic reactions including hypotension (SBP\\< 90 mm Hg or a fall in BP \\>30 mm Hg below baseline), urticaria, flushing, wheezing and/or angioedema'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['STEMI'], 'conditions': ['STEMI']}, 'descriptionModule': {'briefSummary': 'The PANACEA trial is an investigator-initiated prospective, single-center, two-arm, non-blinded pilot randomized controlled trial of high-dose IV N-Acetylcysteine therapy used as an adjunct to pharmaco-invasive reperfusion in patients presenting early after a large STEMI.', 'detailedDescription': 'Patients presenting with ST-segment elevation myocardial infarction within 3 hours of symptom onset and satisfying all of the inclusion criteria after informed consent would be randomly allocated to either intravenous N-Acetylcysteine or standard treatment using a 1:1 allocation ratio. Those randomized to IV N-Acetylcysteine would be administered a bolus of 1200 mg over 0.5 hours (in 5% Dextrose) followed by 600mg/hour for the remaining 47.5 hours (in 5% dextrose). A total N-acetylcysteine dose of 29.7 grams is administered over 48 hours. The infusion is continued during the primary percutaneous coronary intervention. Patients would be followed up for a minimum of 90 days. The primary clinical endpoint will be myocardial infarct size measured by late gadolinium enhancement CMR imaging at 3-5 days from first medical contact. Primary feasibility outcome will be the rate of recruitment, the number of patients undergoing cardiac MRI within the stipulated time frame, and completeness of the study data collection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients presenting with STEMI within 3 hours of symptom onset and satisfying all of the following criteria:\n\n1. Patient age ≥ 18 years\n2. Have received thrombolysis, with intend to pursue a pharmaco-invasive reperfusion strategy. Onset of chest pain to reperfusion time of \\< 3hrs.\n3. STEMI involving anterior and/or inferior wall\n4. An absence of baseline Q-waves on the initial ECG: The presence of Q waves defined at baseline using the Selvester QRS screening criteria\n5. Have a high-risk STEMI ECG defined as:\n\n * ≥2mm ST-segment elevation in 2 anterior or lateral leads; or\n * ≥2 mm ST-segment elevation in 2 inferior leads coupled with ST-segment depression in 2 contiguous anterior leads for a total ST-segment deviation of ≥4 mm\n\nExclusion Criteria:\n\n1. Previous myocardial infarction\n2. Known to have moderate to severe LV systolic dysfunction (LV EF\\< 45%)\n3. Known allergy to thrombolytic therapy or NAC\n4. Presence of left bundle branch block\n5. Cardiogenic shock (defined as systolic blood pressure of \\< 90mm Hg, for at least 30 minutes, not responsive to fluid resuscitation)\n6. Permanent pacemaker or cardioverter defibrillator implanted previously\n7. Patients with contra-indications to thrombolytic therapy\n8. Patients with loss of consciousness or confusion\n9. Patients with known chronic kidney disease (GFR \\< 30ml/min/m2) or on dialysis\n10. Current pregnancy\n11. Planned therapy with primary PCI'}, 'identificationModule': {'nctId': 'NCT04023266', 'acronym': 'PANACEA', 'briefTitle': 'A Pilot Randomized Controlled Trial of Intravenous N-acetyl Cysteine in STEMI', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'A Pilot Randomized Controlled Trial of Intravenous N-acetyl Cysteine in Patients Undergoing Pharmaco-invasive Reperfusion Early After an ST-segment Elevation Myocardial Infarction', 'orgStudyIdInfo': {'id': 'Pro00087545'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravenous N-Acetylcysteine arm', 'description': 'On arrival at the recruiting hospital, eligible and consenting STEMI patients randomly allocated to the experimental arm would be administered an intravenous N-Acetylcysteine bolus of 1200 mg over 0.5 hours (in 5% Dextrose) followed by 600mg/hour for the remaining 47.5 hours (in 5% dextrose). A total N-acetylcysteine dose of 29.7 grams is administered over 48 hours.', 'interventionNames': ['Drug: Intravenous N-Acetylcysteine']}, {'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'Patients randomized to this arm would receive no experimental therapies and would continue to receive all standard guideline recommended medical therapies and interventions.'}], 'interventions': [{'name': 'Intravenous N-Acetylcysteine', 'type': 'DRUG', 'otherNames': ['Generic'], 'description': 'Intravenous N-acetyl cysteine bolus and infusion as described in the experimental arm.', 'armGroupLabels': ['Intravenous N-Acetylcysteine arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Michelle Graham, MD. FRCPC', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Alberta'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'ON publication of trial the study protocol will be detailed. The ICF has been uploaded on this site.', 'ipdSharing': 'YES', 'description': 'Data regarding IPD will be made available on reasonable request', 'accessCriteria': 'Study protocol will be published'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}