Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2026-01-01 @ 12:32 PM
Study NCT ID:
NCT03893435
Status:
COMPLETED
Last Update Posted:
2022-10-06
First Post:
2019-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Sacubitril/Valsartan in Post-acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000717211', 'term': 'sacubitril'}, {'id': 'D000068756', 'term': 'Valsartan'}, {'id': 'C549068', 'term': 'sacubitril and valsartan sodium hydrate drug combination'}], 'ancestors': [{'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014633', 'term': 'Valine'}, {'id': 'D000597', 'term': 'Amino Acids, Branched-Chain'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-04', 'studyFirstSubmitDate': '2019-03-10', 'studyFirstSubmitQcDate': '2019-03-25', 'lastUpdatePostDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'One week major adverse cerebrovascular and cardiovascular events (MACCE)', 'timeFrame': '1 week after AMI', 'description': 'Major adverse cerebrovascular and cardiovascular events (MACCE) will be assessed 1 week after AMI'}, {'measure': 'Twenty four weeks major adverse cerebrovascular and cardiovascular events (MACCE)', 'timeFrame': '24 weeks after AMI', 'description': 'Major adverse cerebrovascular and cardiovascular events (MACCE) will be assessed 24 weeks after AMI'}, {'measure': 'Change in the ejection fraction during hospital stay, 3 months and 6 months after AMI.', 'timeFrame': 'In hospital, 3 months and 6 months after AMI', 'description': 'Change in the ejection fraction assessed by transthoracic echocardiography assessment (TTE) during hospital stay, 3 months and 6 months after AMI.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'Sacubitril/Valsartan (SAC/VAL) is a new treatment of congestive heart failure (CHF) recently indicated as class I, level of evidence B in the recent European Society of Cardiology (ESC) guidelines 2016 of CHF. PARADIGM-HF trial demonstrated a significant improvement of morbidity and mortality with SAC/VAL in comparison to enalapril. So far, no data available about the effect of usage of SAC/VAL post-acute myocardial infarction (AMI) except in animal experimental models.\n\nThe purpose of the research is evaluation of the effects of SAC/VAL in post-AMI in comparison to the traditional Angiotensin Converting Enzyme inhibitors (ACEs inhibitors) or Angiotensin II Receptor Blockers (ARBs) in a real-life clinical trial in treatment of post-AMI patients with reduced left ventricular (LV) systolic function.', 'detailedDescription': 'Background and study rationale:\n\nSacubitril/Valsartan (SAC/VAL) is now approved by the U.S. Food and Drug Administration (FDA) for heart failure with reduced ejection fraction (HFrEF) and also, recently indicated as class I indication, level of evidence B in the European Society of Cardiology (ESC) guidelines 2016 on congestive heart failure (CHF).(1) PARADIGM-HF trial demonstrated that morbidity and mortality can be improved with SAC/VAL In comparison to enalapril, it reduced the occurrence of cardiovascular death or hospitalization for CHF by 20% with a 16% reduction in all-cause mortality.(2) So far, no available data about the effect of usage of SAC/VAL in post-AMI except in animal experimental models that proved efficacy of SAC/VAL in preventing AMI-induced LV dysfunction compared with SAC/VAL, also significantly attenuated LV scar size following AMI compared with placebo .(3)\n\nAim of the work:\n\n* This study aims to investigate the effects of SAC/VAL in post-AMI through using it instead of conventional Angiotensin Converting enzyme inhibitors (ACEs inhibitors) or Angiotensin II Receptor Blockers (ARBs) in treatment of post-AMI patients with reduced left ventricular (LV) systolic function.\n* Design: Randomized open label interventional clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post-AMI patients who underwent successful PPCI and LVEF ≤40%.\n\nExclusion Criteria:\n\n* Post-AMI patients who underwent successful PPCI and LVEF \\>40%.\n* History of hypersensitivity or allergy to any of the study drugs, as well as known or suspected contraindications to the study drugs.\n* Symptomatic hypotension and/or an SBP \\< 100 mmHg.\n* Estimated GFR \\< 30 mL/min/1.73m2 as measured by the simplified MDRD formula or serum potassium \\> 5.2 mmol/L.'}, 'identificationModule': {'nctId': 'NCT03893435', 'acronym': 'RSVP-AMI', 'briefTitle': 'The Role of Sacubitril/Valsartan in Post-acute Myocardial Infarction', 'organization': {'class': 'NETWORK', 'fullName': 'The Young Investigator Group of Cardiovascular Research'}, 'officialTitle': 'The Role of Sacubitril/Valsartan in Post-acute Myocardial Infarction: The RSVP-AMI Trial', 'orgStudyIdInfo': {'id': 'YIG01201902'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sacubitril/Valsartan', 'description': 'In successfully revascularized post-AMI patients with LVEF ≤40% Sacubitril/Valsartan with the recommended starting dose: 24 mg/26 mg PO BID. After 2-4 weeks, the dose will be doubled to the target maintenance dose of 97 mg/103 mg PO BID (if tolerated) for 6 months.', 'interventionNames': ['Drug: Sacubitril / Valsartan Oral Tablet [Entresto]']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Valsartan', 'description': 'In successfully revascularized post-AMI patients with LVEF ≤40% Valsartan with an initial dose of 40 mg PO BID, with subsequent titrations to target maintenance dose of 160 mg BID as tolerated.', 'interventionNames': ['Drug: Sacubitril / Valsartan Oral Tablet [Entresto]']}], 'interventions': [{'name': 'Sacubitril / Valsartan Oral Tablet [Entresto]', 'type': 'DRUG', 'otherNames': ['ARNI'], 'description': 'Sacubitril/Valsartan with the recommended starting dose: 24 mg/26 mg PO BID. After 2-4 weeks, the dose will be doubled to the target maintenance dose of 97 mg/103 mg PO BID (if tolerated) for 6 months.', 'armGroupLabels': ['Sacubitril/Valsartan', 'Valsartan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21524', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Andalusia Hospitals', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Sherif S Elbeltagui, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assisstant Professor of Cardiology, University of Alexandria, Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Young Investigator Group of Cardiovascular Research', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Registrar of Cardiology and Angiology', 'investigatorFullName': 'Abdallah Almaghraby', 'investigatorAffiliation': 'The Young Investigator Group of Cardiovascular Research'}}}}