Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT06769256
Status:
RECRUITING
Last Update Posted:
2025-05-13
First Post:
2024-12-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intracoronary rhTNK-tPA Versus Tirofiban in Patients With STEMI and High Thrombus Burden
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077466', 'term': 'Tirofiban'}], 'ancestors': [{'id': 'D014443', 'term': 'Tyrosine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-08', 'studyFirstSubmitDate': '2024-12-26', 'studyFirstSubmitQcDate': '2025-01-09', 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corrected TIMI frame count (CTFC)', 'timeFrame': 'At the end of Percutaneous Coronary Intervention procedure'}], 'secondaryOutcomes': [{'measure': 'TIMI flow grade', 'timeFrame': 'At the end of Percutaneous Coronary Intervention procedure'}, {'measure': 'Complete ST-segment resolution (STR)', 'timeFrame': '1 hour post PCI procedure'}, {'measure': 'Left ventricular ejection fraction (LVEF)', 'timeFrame': 'Baseline, 1 month, 6 months and 12 months'}, {'measure': 'A composite of all-cause death, recurrent myocardial infarction, ischemic stroke, and hospitalization for heart failure', 'timeFrame': '1 month, 6 months and 12 months'}, {'measure': 'Bleeding events according to the BARC bleeding classification', 'timeFrame': 'At hospital discharge, an average of 2 days after primary PCI, 1 month, 6 months and 12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ST-segment Elevation Myocardial Infarction (STEMI)']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the efficacy and safety of intracoronary rhTNK-tPA or Tirofiban in patients with ST-segment elevation myocardial infarction and high thrombus burden. The main questions it aims to answer are:\n\n* Is the efficacy of intracoronary rhTNK-tPA non-inferior to intracoronary Tirofiban for the treatment of ST-segment elevation myocardial infarction in patients wiht high thrombus burden?\n* Does intracoronary rhTNK-tPA increase the incidence of bleeding events?\n\nThis multicenter RCT study plans to enroll 300 patients, who are randomly divided into two groups: intracoronary rhTNK-tPA or Tirofiban by 1:1. The primary efficacy endpoint was post-PCI corrected TIMI frame count (CTFC). Major adverse events (death, recurrent myocardial infarction, ischemic stroke, or hospitalization for heart failure) were observed at 1 year follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-75 years old;\n* STEMI within 12 hours of onset;\n* TIMI flow grade 0-2 or TIMI thrombus grade ≥4 after thrombus aspiration or balloon dilation\n* Radial artery access\n\nExclusion Criteria:\n\n* A functional coronary collateral supply (Rentrop grade≥2) to the infarctrelated artery\n* Known or suspected old myocardial infarction of target vessels\n* Rescue PCI\n* Cardiogenic shock\n* Contraindications to Tirofiban or rhTNK-tPA\n* Severe hepatic and renal insufficiency (alanine aminotransferase ≥5 upper limit of normal; estimated glomerular filtration rate \\<30ml/min/1.73m2, or on dialysis)\n* Prolonged (\\> 10 minutes) cardiopulmonary resuscitation\n* Definite mechanical complications (including ventricular septal perforation, or rupture of the Papillary tendon bundle, or rupture of the left ventricular free wall)\n* Severe chronic obstructive pulmonary disease or respiratory failure\n* Severe infection\n* Neurological disorders\n* Malignant tumors or other pathophysiological conditions with an expected survival time of less than 1 year\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT06769256', 'acronym': 'H2-THROMBUS', 'briefTitle': 'Intracoronary rhTNK-tPA Versus Tirofiban in Patients With STEMI and High Thrombus Burden', 'organization': {'class': 'OTHER', 'fullName': 'Henan Institute of Cardiovascular Epidemiology'}, 'officialTitle': 'Effects of Intracoronary Recombinant Human TNK Tissue-type Plasminogen Activator Versus Tirofiban on Myocardial Perfusion and Clinical Prognosis in Patients With ST-segment Elevation Myocardial Infarction and High Thrombus Burden: a Multicenter, Randomized, Controlled, Single-blind, Non-inferior Study', 'orgStudyIdInfo': {'id': 'HenanICE202412'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intracoronary rhTNK-tPA', 'interventionNames': ['Drug: rhTNK-tPA, 4-8 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intracoronary Tirofiban', 'interventionNames': ['Drug: Tirofiban']}], 'interventions': [{'name': 'rhTNK-tPA, 4-8 mg', 'type': 'DRUG', 'description': 'Intracoronary influsion of rhTNK-tPA (4 mg). After 10 minutes of administration, 4 mg may be given again if the thrombus burden is not significantly reduced.', 'armGroupLabels': ['Intracoronary rhTNK-tPA']}, {'name': 'Tirofiban', 'type': 'DRUG', 'description': 'Intracoronary influsion of Tirofiban (10 µg/kg) , and then administered intravenously at 0.075-0.15 µg/kg.min for 36 h or longer', 'armGroupLabels': ['Intracoronary Tirofiban']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'You Zhang', 'role': 'CONTACT', 'phone': '+8637158681037'}], 'facility': 'Fuwai Central China Cardiovascular Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'You Zhang', 'role': 'CONTACT', 'email': '13598019682@126.com', 'phone': '+86 37158681037'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan Institute of Cardiovascular Epidemiology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Chuanyu Gao', 'investigatorAffiliation': 'Henan Institute of Cardiovascular Epidemiology'}}}}