Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2026-01-29 @ 2:11 PM
Study NCT ID:
NCT03742050
Status:
COMPLETED
Last Update Posted:
2023-09-29
First Post:
2018-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Placebo-controlled Trial of Percutaneous Coronary Intervention for the Relief of Stable Angina
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060050', 'term': 'Angina, Stable'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062645', 'term': 'Percutaneous Coronary Intervention'}, {'id': 'D000800', 'term': 'Angioplasty, Balloon'}], 'ancestors': [{'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D017130', 'term': 'Angioplasty'}, {'id': 'D002404', 'term': 'Catheterization'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 439}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-27', 'studyFirstSubmitDate': '2018-11-13', 'studyFirstSubmitQcDate': '2018-11-13', 'lastUpdatePostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in angina symptom score between groups', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in treadmill exercise time', 'timeFrame': '12 weeks'}, {'measure': 'Angina severity as assessed by Canadian Cardiovascular Society class', 'timeFrame': '12 weeks'}, {'measure': 'Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire', 'timeFrame': '12 weeks'}, {'measure': 'Quality of life as assessed with the EQ-5D-5L questionnaire', 'timeFrame': '12 weeks'}, {'measure': 'Change in dobutamine stress echocardiography score', 'timeFrame': '12 weeks'}, {'measure': 'Need for anti-anginal medication introduction and up-titration', 'timeFrame': '12 weeks'}, {'measure': 'Admission for acute coronary syndrome or unscheduled coronary angiography', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stable Angina'], 'conditions': ['Stable Angina']}, 'referencesModule': {'references': [{'pmid': '39462291', 'type': 'DERIVED', 'citation': "Foley MJ, Rajkumar CA, Ahmed-Jushuf F, Simader F, Chotai S, Seligman H, Macierzanka K, Davies JR, Keeble TR, O'Kane P, Haworth P, Routledge H, Kotecha T, Clesham G, Williams R, Din J, Nijjer SS, Curzen N, Sinha M, Petraco R, Spratt J, Sen S, Cole GD, Harrell FE Jr, Howard JP, Francis DP, Shun-Shin MJ, Al-Lamee R; ORBITA-2 Investigators. Fractional Flow Reserve and Instantaneous Wave-Free Ratio as Predictors of the Placebo-Controlled Response to Percutaneous Coronary Intervention in Stable Coronary Artery Disease. Circulation. 2025 Jan 21;151(3):202-214. doi: 10.1161/CIRCULATIONAHA.124.072281. Epub 2024 Oct 27."}, {'pmid': '38015442', 'type': 'DERIVED', 'citation': "Rajkumar CA, Foley MJ, Ahmed-Jushuf F, Nowbar AN, Simader FA, Davies JR, O'Kane PD, Haworth P, Routledge H, Kotecha T, Gamma R, Clesham G, Williams R, Din J, Nijjer SS, Curzen N, Ruparelia N, Sinha M, Dungu JN, Ganesananthan S, Khamis R, Mughal L, Kinnaird T, Petraco R, Spratt JC, Sen S, Sehmi J, Collier DJ, Sohaib A, Keeble TR, Cole GD, Howard JP, Francis DP, Shun-Shin MJ, Al-Lamee RK; ORBITA-2 Investigators. A Placebo-Controlled Trial of Percutaneous Coronary Intervention for Stable Angina. N Engl J Med. 2023 Dec 21;389(25):2319-2330. doi: 10.1056/NEJMoa2310610. Epub 2023 Nov 11."}, {'pmid': '35156616', 'type': 'DERIVED', 'citation': 'Nowbar AN, Rajkumar C, Foley M, Ahmed-Jushuf F, Howard JP, Seligman H, Petraco R, Sen S, Nijjer SS, Shun-Shin MJ, Keeble TR, Sohaib A, Collier D, McVeigh P, Harrell FE, Francis DP, Al-Lamee RK. A double-blind randomised placebo-controlled trial of percutaneous coronary intervention for the relief of stable angina without antianginal medications: design and rationale of the ORBITA-2 trial. EuroIntervention. 2022 Apr 22;17(18):1490-1497. doi: 10.4244/EIJ-D-21-00649.'}]}, 'descriptionModule': {'briefSummary': 'ORBITA-2 is a double blinded randomised placebo-controlled trial comparing the effects of coronary angioplasty versus placebo procedure on symptoms of stable angina without background anti-anginal therapy. Follow-up will be at 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nORBITA-2 will enrol patients who meet all 3 of the following criteria:\n\n1. Angina or angina-equivalent symptoms\n2. Anatomical evidence of significant coronary stenosis in at least one vessel, either: a. Invasive diagnostic coronary angiogram indicating ≥ 70% stenosis b. CT coronary angiography indicating ≥ 90% stenosis\n3. Evidence of ischaemia, arising from at least one of the following options:\n\n 1. Positive dobutamine stress echocardiography\n 2. Positive cardiac MRI perfusion scan\n 3. Positive nuclear medicine myocardial perfusion scan\n 4. Invasive pressure wire assessment suggestive of ischaemia, as judged by the interventional cardiologist, at the time of diagnostic angiogram or research angiogram\n\nExclusion Criteria:\n\n1. Age younger than 18\n2. Age older than 85\n3. Recent acute coronary event\n4. Previous coronary artery bypass graft surgery\n5. Significant left main stem coronary disease\n6. Chronic total occlusion in the target vessel\n7. Contraindication to percutaneous coronary intervention or drug-eluting stent implantation\n8. Contraindication to antiplatelet therapy\n9. Severe valvular disease\n10. Severe LV systolic impairment\n11. Severe respiratory disease\n12. Life expectancy less than 2 years, pregnancy, unable to consent'}, 'identificationModule': {'nctId': 'NCT03742050', 'acronym': 'ORBITA-2', 'briefTitle': 'A Placebo-controlled Trial of Percutaneous Coronary Intervention for the Relief of Stable Angina', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'A Placebo-controlled Trial of Percutaneous Coronary Intervention for the Relief of Stable Angina', 'orgStudyIdInfo': {'id': '18SM4531'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Percutaneous coronary intervention', 'description': 'Percutaneous coronary intervention with drug-eluting stents and modern techniques', 'interventionNames': ['Procedure: Percutaneous coronary intervention']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo percutaneous coronary intervention', 'description': 'Placebo percutaneous coronary intervention', 'interventionNames': ['Procedure: Percutaneous coronary intervention']}], 'interventions': [{'name': 'Percutaneous coronary intervention', 'type': 'PROCEDURE', 'otherNames': ['Coronary angioplasty'], 'description': 'Percutaneous coronary intervention with drug-eluting stents aiming to achieve complete revascularisation', 'armGroupLabels': ['Percutaneous coronary intervention', 'Placebo percutaneous coronary intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Basildon', 'country': 'United Kingdom', 'facility': 'Basildon and Thurrock Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.56844, 'lon': 0.45782}}, {'zip': 'BH77DW', 'city': 'Bournemouth', 'country': 'United Kingdom', 'facility': 'Royal Bournemouth Hospital', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}, {'zip': 'HP11 2TT', 'city': 'High Wycombe', 'country': 'United Kingdom', 'facility': 'Wycombe Hospital', 'geoPoint': {'lat': 51.62907, 'lon': -0.74934}}, {'zip': 'W12 0HS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College Healthcare NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Free Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Portsmouth', 'country': 'United Kingdom', 'facility': 'Queen Alexandra Hospital', 'geoPoint': {'lat': 50.79899, 'lon': -1.09125}}, {'city': 'Reading', 'country': 'United Kingdom', 'facility': 'Royal Berkshire NHS Foundation Trust', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}, {'zip': 'UB9 6JH', 'city': 'Uxbridge', 'country': 'United Kingdom', 'facility': 'Harefield Hospital', 'geoPoint': {'lat': 51.5489, 'lon': -0.48211}}], 'overallOfficials': [{'name': 'Darrel Francis, MRCP', 'role': 'STUDY_CHAIR', 'affiliation': 'Imperial College London'}, {'name': 'Christopher A Rajkumar', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Imperial College London'}, {'name': 'Rasha Al-Lamee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'collaborators': [{'name': 'Basildon and Thurrock Hospitals NHS FoundationTrust', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}