Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT04962451
Status:
COMPLETED
Last Update Posted:
2021-07-15
First Post:
2021-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of the Efficacy of Ticagrelor Combined With ASA to ASA Alone in Patients With Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077486', 'term': 'Ticagrelor'}], 'ancestors': [{'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-04', 'studyFirstSubmitDate': '2021-06-27', 'studyFirstSubmitQcDate': '2021-07-04', 'lastUpdatePostDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of adverse events', 'timeFrame': 'At day 7 after participants included into the research', 'description': 'The event that patients have stroke or die'}, {'measure': 'Occurrence of adverse events', 'timeFrame': 'At day 30 after participants included into the research', 'description': 'The event that patients have stroke or die'}, {'measure': 'Occurrence of adverse events', 'timeFrame': 'At day 60 after participants included into the research', 'description': 'The event that patients have stroke or die'}], 'secondaryOutcomes': [{'measure': 'Tool assessment result', 'timeFrame': 'At day 60 after participants included into the research', 'description': 'Score of Modified Rankin Scale'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebrovascular Accident', 'Cerebrovascular Accident, Acute']}, 'descriptionModule': {'briefSummary': 'Cerebrovascular disease is the main cause of death and severe long-term disability worldwide. Antiplatelet drugs are the main drugs for ischemic stroke and TIA. Cyclooxygenase inhibitor acetylsalicylic acid (ASA) has always been the most widely studied antiplatelet therapy. The studies of acrates of aliscon body evaluated the efficacy and safety of ticagrelor monotherapy in preventing major vascular events in patients with AIS or TIA. The results showed that the number of patients with endpoint events in ticagrelor group was less than that in ASA group, However, it has not been proved that ticagrelor monotherapy is better than ASA. The purpose of this study is to prove that ticagrelor is better than ASA.', 'detailedDescription': 'Cerebrovascular disease is the main cause of death and severe long-term disability worldwide. Antiplatelet drugs are the main drugs for ischemic stroke and TIA. Cyclooxygenase inhibitor acetylsalicylic acid (ASA) has always been the most widely studied antiplatelet therapy. The studies of acrates of aliscon body evaluated the efficacy and safety of ticagrelor monotherapy in preventing major vascular events in patients with AIS or TIA. The results showed that the number of patients with endpoint events in ticagrelor group was less than that in ASA group, However, it has not been proved that ticagrelor monotherapy is better than ASA. The purpose of this study is to prove that ticagrelor is better than ASA. The study will be designed as a randomized, double-blind, placebo-controlled, parallel grouping study and conducted in multiple centers to ensure the representation of multiple countries, races and races, so as to ensure that the results of the study can be widely applied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Over 40 years old\n2. Acute ischemic attack\n3. Symptoms occurred within 24 hours after randomization\n\nExclusion Criteria:\n\n1. Dual antiplatelet therapy with ASA and P2Y12 inhibitors is needed\n2. Antiplatelet agents other than ASA\n3. Anticoagulant therapy\n4. Have any atrial fibrillation / flutter\n5. Renal failure requiring dialysis\n6. During pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT04962451', 'briefTitle': 'Comparison of the Efficacy of Ticagrelor Combined With ASA to ASA Alone in Patients With Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Efficacy and Safety of Ticagrelor Combined With ASA Versus ASA Alone in Preventing Stroke and Death in Patients With Acute Ischemic Stroke or Transient Ischemic Attack: a Randomized, Double-blind, Placebo-controlled, International Multicenter Phase III Clinical Study', 'orgStudyIdInfo': {'id': 'D2017121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'interventionNames': ['Drug: ticagrelor + ASA']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'interventionNames': ['Drug: Placebo+ASA']}], 'interventions': [{'name': 'ticagrelor + ASA', 'type': 'DRUG', 'description': 'On day 1, ticagrelor loading dose (2 tablets, ticagrelor 90mg) was given, followed by ticagrelor 90mg, twice daily Basic treatment: the first day received ASA loading dose, 300-325mg, and the server received ASA 75-100mg, once a day', 'armGroupLabels': ['Intervention group']}, {'name': 'Placebo+ASA', 'type': 'DRUG', 'description': 'Placebo loading dose on day 1 (2 tablets, matched with ticagrelor 90mg), followed by placebo twice daily (matched with ticagrelor 90mg) Basic treatment: the first day received ASA loading dose, 300-325mg, and the server received ASA 75-100mg, once a day', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Xiaogang Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}