Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-02-26 @ 4:13 PM
Study NCT ID:
NCT01495520
Status:
UNKNOWN
Last Update Posted:
2013-03-07
First Post:
2011-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ranolazine for Improving Symptoms of Palpitations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069458', 'term': 'Ranolazine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-03-06', 'studyFirstSubmitDate': '2011-12-15', 'studyFirstSubmitQcDate': '2011-12-19', 'lastUpdatePostDateStruct': {'date': '2013-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of symptoms of palpitations', 'timeFrame': 'Up to 30 days', 'description': 'Occurrence of symptoms of palpitations'}], 'secondaryOutcomes': [{'measure': 'Occurrence of arrhythmia in case of symptoms of palpitations', 'timeFrame': 'Up to 30 days', 'description': 'Definition of presence, number, type and duration of the arrhythmia in case of the patient-reported symptoms of palpitations'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Arrhythmias', 'palpitations'], 'conditions': ['Ischemic Heart Disease']}, 'descriptionModule': {'briefSummary': "Patients with ischemic heart disease often report multiple symptoms, including angina and palpitations. Ranolazine has antiarrhythmic effects which are largely a result of the drug's effect on multiple ion channels. It remains unknown, however, whether the favorable effects of ranolazine on symptoms and arrhythmias are maintained over time. Aim of this study is to test the hypothesis that chronic treatment with ranolazine can improve the symptomatic status of patients with ischemic heart disease by reducing the occurrence of palpitations.", 'detailedDescription': "Background:\n\nPatients with ischemic heart disease often report multiple symptoms, including angina and palpitations.\n\nRanolazine is a novel antianginal and antiischemic drug that reduces intracellular sodium and calcium accumulation during ischemia thus limiting ischemic injury. Furthermore, ranolazine has antiarrhythmic effects which are largely a result of the drug's effect on multiple ion channels.\n\nIt has previously been shown that treatment with ranolazine can reduce the frequency of supraventricular and ventricular tachycardia in the short term. In a subgroup analysis of the MERLIN-TIMI 36 trial, the continuous ECGs of 6,351 patients were analyzed. The results showed that, in comparison with placebo, treatment with ranolazine resulted in fewer episodes of ventricular tachycardia that lasted 8 beats or longer (5.3% versus 8.3%; P \\<0.001), and in fewer episodes of supraventricular tachycardia (44.7% versus 55%; P \\<0.001) and new-onset atrial fibrillation (1.7% versus 2.4%; P=0.08).\n\nIt remains unknown, however, whether the favorable effects of ranolazine on symptoms and arrhythmias are maintained over time.\n\nPurpose:\n\nThe primary objective of this study is to test the hypothesis that chronic treatment with ranolazine can improve the symptomatic status of patients with ischemic heart disease by reducing the occurrence of palpitations."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptoms of palpitations\n* Angiographically-proven coronary artery disease\n* Stable conditions\n* No recent acute coronary syndromes\n* Able to understand and willing to sign the informed consent form\n* Symptomatic patients (palpitation) with stable angina pectoris already on therapy with beta-blockers and/or calcium antagonists.\n\nExclusion Criteria:\n\n* Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours\n* Severe renal failure\n* Severe hepatic failure'}, 'identificationModule': {'nctId': 'NCT01495520', 'acronym': 'RYPPLE', 'briefTitle': 'Ranolazine for Improving Symptoms of Palpitations', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Ranolazine for the Treatment of sYmPtoms of PaLpitations in patiEnts With Ischemic Heart Disease - The RYPPLE Trial', 'orgStudyIdInfo': {'id': '671/2011/D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ranolazine', 'description': 'Patients will receive ranolazine 750 mg bid for 30 days', 'interventionNames': ['Drug: Ranolazine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients will receive placebo for 30 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ranolazine', 'type': 'DRUG', 'otherNames': ['Ranexa TM, Gilead, US'], 'description': 'os, pill, 750 mg, b.i.d., 30 days', 'armGroupLabels': ['Ranolazine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'os, pill, b.i.d., 30 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Francesco Pelliccia, MD', 'role': 'CONTACT', 'email': 'f.pelliccia@mclink.it', 'phone': '+39064997'}], 'overallOfficials': [{'name': 'Francesco Pelliccia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Sapienza'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Francesco Pelliccia', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}