Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-01 @ 11:24 AM
Study NCT ID:
NCT04971356
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-14
First Post:
2021-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
1-month DAPT Plus 5-month Ticagrelor Monotherapy Versus 12-month DAPT in Patients With Drug-coated Balloon
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D000077486', 'term': 'Ticagrelor'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1948}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-12', 'studyFirstSubmitDate': '2021-07-20', 'studyFirstSubmitQcDate': '2021-07-20', 'lastUpdatePostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Net adverse clinical events (NACE)', 'timeFrame': '12 months', 'description': 'NACE is a composite clinical endpoint of all-cause death, any stroke, any MI, any revascularization and BARC type 3 or 5 bleeding events'}], 'secondaryOutcomes': [{'measure': 'Any ischemic or bleeding event', 'timeFrame': '1, 6 and 12 months', 'description': 'Any ischemic and bleeding event includes any all-cause death, any stroke, MI, BARC-defined type 3 bleeding, any revascularization and BARC-defined type 2 bleeding events'}, {'measure': 'BARC type 3 or 5 bleeding events', 'timeFrame': '1, 6 and 12 months', 'description': 'Bleeding events type 3 or 5 defined by BARC (Bleeding Academic Research Consortium) criteria'}, {'measure': 'BARC type 2 ,3 or 5 bleeding events', 'timeFrame': '1, 6 and 12 months', 'description': 'Bleeding events type 2, 3 or 5 defined by BARC (Bleeding Academic Research Consortium) criteria'}, {'measure': 'BARC defined type 2 bleeding events', 'timeFrame': '1, 6 and 12 months', 'description': 'Bleeding events type 2 defined by BARC (Bleeding Academic Research Consortium) criteria'}, {'measure': 'Rate of NACE', 'timeFrame': '1 and 6 months', 'description': 'NACE is a composite clinical endpoint of all-cause death, any stroke, any MI, any revascularization and BARC type 3 or 5 bleeding events'}, {'measure': 'Device-oriented Composite Endpoint (DoCE)', 'timeFrame': '1, 6 and 12 months', 'description': 'DoCE is a composite clinical endpoint of cardiac cause death, target vessel myocardial infraction (TV-MI), and Clinically individual target lesion revascularization (CI-TLR)'}, {'measure': 'Cardiac death', 'timeFrame': '1, 6 and 12 months', 'description': 'Rates of individual components of DoCE'}, {'measure': 'Target vessel myocardial infraction (TV-MI)', 'timeFrame': '1, 6 and 12 months', 'description': 'Rates of individual components of DoCE'}, {'measure': 'Clinically individual target lesion revascularization (CI-TLR)', 'timeFrame': '1, 6 and 12 months', 'description': 'Rates of individual components of DoCE'}, {'measure': 'Patient-oriented Composite Endpoint (PoCE)', 'timeFrame': '1, 6 and 12 months', 'description': 'The primary safety endpoint of PoCE is defined as all-cause death, any stroke, any MI, any revascularization'}, {'measure': 'All-cause death', 'timeFrame': '1, 6 and 12 months', 'description': 'Rates of individual components of PoCE'}, {'measure': 'Any MI', 'timeFrame': '1, 6 and 12 months', 'description': 'Rates of individual components of PoCE'}, {'measure': 'Any stroke', 'timeFrame': '1, 6 and 12 months', 'description': 'Rates of individual components of PoCE'}, {'measure': 'Any revascularization', 'timeFrame': '1, 6 and 12 months', 'description': 'Rates of individual components of PoCE'}, {'measure': 'Target vessel failure (TVF)', 'timeFrame': '1, 6 and 12 months', 'description': 'Target vessel failure is defined as cardiovascular death, target vessel myocardial infraction (TV-MI), and clinically-indicated target vessel revascularization'}, {'measure': 'Clinically-indicated target vessel revascularization', 'timeFrame': '1, 6 and 12 months', 'description': 'Rates of individual components of TVF'}, {'measure': 'Definite/Probable stent thrombosis rates', 'timeFrame': '1, 6 and 12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ticagrelor Monotherapy', 'Acute coronary syndrome', 'Drug-coated balloons'], 'conditions': ['Antiplatelet Drug', 'Acute Coronary Syndrome', 'Angioplasty, Balloon']}, 'referencesModule': {'references': [{'pmid': '40164448', 'type': 'DERIVED', 'citation': 'Gao C, Zhu B, Ouyang F, Wen S, Xu Y, Jia W, Yang P, He Y, Zhong Y, Zhou Y, Guo Z, Shen G, Ma L, Xu L, Xue Y, Hu T, Wang Q, Liu Y, Zhang R, Liu J, Jiang Z, Xia J, Garg S, van Geuns RJ, Capodanno D, Onuma Y, Wang D, Serruys P, Tao L; REC-CAGEFREE II Investigators. Stepwise dual antiplatelet therapy de-escalation in patients after drug coated balloon angioplasty (REC-CAGEFREE II): multicentre, randomised, open label, assessor blind, non-inferiority trial. BMJ. 2025 Mar 31;388:e082945. doi: 10.1136/bmj-2024-082945.'}, {'pmid': '38245724', 'type': 'DERIVED', 'citation': 'Gao C, Zhu B, Liu J, Jiang Z, Hu T, Wang Q, Liu Y, Yuan M, Li F, Zhang R, Xia J, Onuma Y, Wang D, Serruys P, Tao L; REC-CAGEFREE II Study Group. Randomized evaluation of 5-month Ticagrelor monotherapy after 1-month dual-antiplatelet therapy in patients with acute coronary syndrome treated with drug-coated balloons: REC-CAGEFREE II trial rationale and design. BMC Cardiovasc Disord. 2024 Jan 20;24(1):62. doi: 10.1186/s12872-024-03709-1.'}]}, 'descriptionModule': {'briefSummary': 'Drug-Coated Balloon (DCB) angioplasty is similar to plain old balloon angioplasty procedurally, but there is an anti-proliferative medication paclitaxel coated to the balloon. Treating ISR lesions with the DCB has the theoretical advantage of avoiding multiple stent layers and respecting the vessel anatomy. DCB has shown promising results for the treatment of ISR. Currently, DCB has a Class I indication to treat ISR recommended by European Society of Cardiology guidelines. In addition, some interventional cardiologist has also applied DCB in de novo lesions in their clinical practice.\n\nBleeding after PCI remains a substantial clinical problem. Bleeding post-PCI increases the risk of adverse outcomes such as death, non-fatal myocardial infarction, and prolongs hospital stay. Clinical data has suggested that major bleeding post-PCI would increase the risk of mortality 5.7-fold. The antiplatelet medications are the major cause of bleeding events post-PCI.\n\nCurrent guidelines for stents recommended DAPT of aspirin plus a P2Y12 inhibitor for at least 12 months after stent implantation in patients with the acute coronary syndrome. Compared with the DES, because of the absence of metal inside the coronary artery, the use of DCB might theoretically allow shorter duration antiplatelet therapy. However, the optimal course of DAPT for the DCB treated patients remains controversial.\n\nIn 2013, the consensus from the German group suggested that for the acute coronary syndrome, DAPT should be used for 12 months. The consensus of DAPT developed by the European Society of Cardiology (ESC) in 2017 stated that "in patients treated with DCB, dedicated clinical trials investigating the optimal duration of DAPT are lacking." So far, there are no randomized data showing the optimal DAPT duration for the DCB treated patients.\n\nIn the current study, we use Aspirin + Ticagrelor for 1-month followed by Ticagrelor monotherapy for 5-month, afterward, Aspirin monotherapy for 6 months to be the antiplatelet regimen in the experimental arm, to compare with the Reference arm, which is Aspirin + Ticagrelor for 12-month in a non-inferiority statistical assumption, aiming to investigate the optimal duration of the DAPT in ACS patients after DCB treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with an indication for PCI due to acute coronary syndrome\n2. All target lesions can be successful treatment of PCI with drug-coated balloon (DCB)\n3. Patients who are able to complete the follow-up and compliant to the prescribed medication\n\nExclusion Criteria:\n\n1. Under the age of 18 or Older than 80 years old\n2. Unable to give informed consent\n3. Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice)\n4. Known contraindication to medications such as Heparin, antiplatelet drugs, or contrast.\n5. Currently participating in another trial and not yet at its primary endpoint\n6. Planned elective surgery\n7. Concurrent medical condition with a life expectancy of less than 1 years\n8. Previous intracranial haemorrhage\n9. Need long-term oral anticoagulant therapy\n10. Cardiogenic shock\n11. Previous stent implantation 6 month\n12. In-stent thrombosis\n13. Target lesion located in surgical conduit'}, 'identificationModule': {'nctId': 'NCT04971356', 'acronym': 'CAGEFREEII', 'briefTitle': '1-month DAPT Plus 5-month Ticagrelor Monotherapy Versus 12-month DAPT in Patients With Drug-coated Balloon', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Aspirin Plus Ticagrelor for 1 Month Followed by 5 Months Ticagrelor Monotherapy Versus Aspirin Plus Ticagrelor for 12 Months in Acute Coronary Syndrome Patients With Drug-coated Balloon: a Multicentre, Randomized, Non-inferiority Trial', 'orgStudyIdInfo': {'id': 'CAGE-FREE II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental arm', 'description': '1-month of Aspirin + Ticagrelor, followed by 5-month of Ticagrelor monotherapy; Afterward, Aspirin monotherapy for 6 months', 'interventionNames': ['Drug: Aspirin 100mg for 1-month (immediately after PCI)', 'Drug: Ticagrelor 90mg for 6-month (immediately after PCI)', 'Drug: Aspirin 100mg for 6-month (6-month post PCI)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference arm', 'description': '12-month Aspirin plus Ticagrelor', 'interventionNames': ['Drug: Aspirin 100mg for 12-month (immediately after PCI)', 'Drug: Ticagrelor 90mg for 12-month (immediately after PCI)']}], 'interventions': [{'name': 'Aspirin 100mg for 1-month (immediately after PCI)', 'type': 'DRUG', 'description': 'Aspirin for 1-month immediately after PCI to be a part of medication treatment in the Experimental arm', 'armGroupLabels': ['Experimental arm']}, {'name': 'Ticagrelor 90mg for 6-month (immediately after PCI)', 'type': 'DRUG', 'description': 'Ticagrelor for 6-month immediately after PCI to be a part of medication treatment in the Experimental arm', 'armGroupLabels': ['Experimental arm']}, {'name': 'Aspirin 100mg for 6-month (6-month post PCI)', 'type': 'DRUG', 'description': 'Aspirin for 6-month at 6 months post-PCI (after the discontinuation of the 6-month Ticagrelor treatment) to be a part of medication treatment in the Experimental arm', 'armGroupLabels': ['Experimental arm']}, {'name': 'Aspirin 100mg for 12-month (immediately after PCI)', 'type': 'DRUG', 'description': 'Aspirin for 12-month immediately after PCI to be a part of medication treatment in the Reference arm', 'armGroupLabels': ['Reference arm']}, {'name': 'Ticagrelor 90mg for 12-month (immediately after PCI)', 'type': 'DRUG', 'description': 'Ticagrelor for 12-month immediately after PCI to be a part of medication treatment in the Reference arm', 'armGroupLabels': ['Reference arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shannxi', 'country': 'China', 'facility': 'Ling Tao', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Ling Tao, MD,PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'Xijing Hospital'}, {'name': 'Patrick Serruys, MD,PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'National University of Ireland, Galway'}, {'name': 'Yoshinobu Onuma, MD,PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'National University of Ireland, Galway'}, {'name': 'Chao Gao, MD,PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'Xijing Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in cardiology, Director of the department of Cardiology', 'investigatorFullName': 'LingTao', 'investigatorAffiliation': 'Xijing Hospital'}}}}