Safety and Efficacy of Percutaneous Coronary Intervention Combined With Thrombolysis at Different Time

NCT ID: NCT03137212

Last Updated: 2017-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-17

Study Completion Date

2020-03-31

Brief Summary

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Patients with acute ST-segment elevation myocardial infarction and thrombolysis indications, will be given the recombinant human prourokinase for thrombolysis treatment, and in accordance with the guidelines, will be treated with coronary angiography examination 3 to 24 hours after thrombolysis. The study will explore the best time for interventional therapy combined with thrombolysis.

Detailed Description

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The noninferiority multicenter, prospective, randomized, controlled study of urokinase of restructuring the original design evaluation (rhPro - UK) at different times after thrombolysis combined with percutaneous coronary intervention(PCI)therapy of acute ST segment elevation myocardial infarction.Patients with acute ST segment elevation myocardial infarction and thrombolysis indications, will be given the recombinant human prourokinase for thrombolysis treatment, and in accordance with the guidelines, will be treated with coronary angiography examination 3 to 24 hours after thrombolysis. The study will explore the best time for interventional therapy combined with thrombolysis.

Conditions

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Acute ST Segment Elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The patients with STEMI will be divided into two group randomly. Patients of A group will be treated by thrombolysis and then 3-6 hours will be treated by PCI. Patients of B group will be treated by thrombolysis and then 6-24 hours will be treated by PCI.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A group

STEMI patients first are given thrombolysis and then transfer to PCI center to be treated by PCI 3-6 hours after thrombolysis if the thrombolysis is successful. if the thrombolysis is not successful, patients will be treated by PCI immediately.

Group Type EXPERIMENTAL

thrombolysis and PCI of A type

Intervention Type COMBINATION_PRODUCT

STEMI patients first are given thrombolysis and then transfer to PCI centers to be treated by PCI 3-6 hours after thrombolysis.

B group

STEMI patients first are given thrombolysis and then transfer to PCI center to be treated by PCI 6-24 hours after thrombolysis if the thrombolysis is successful. if the thrombolysis is not successful, patients will be treated by PCI immediately.

Group Type EXPERIMENTAL

thrombolysis and PCI of B type

Intervention Type COMBINATION_PRODUCT

STEMI patients first are given thrombolysis and then transfer to PCI centers to be treated by PCI 6-24 hours after thrombolysis.

Interventions

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thrombolysis and PCI of A type

STEMI patients first are given thrombolysis and then transfer to PCI centers to be treated by PCI 3-6 hours after thrombolysis.

Intervention Type COMBINATION_PRODUCT

thrombolysis and PCI of B type

STEMI patients first are given thrombolysis and then transfer to PCI centers to be treated by PCI 6-24 hours after thrombolysis.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* Aged 19 to 70 years old, gender not limited
* 30 minutes or more persistent ischemia chest pain, and symptoms can't ease by treated by nitroglycerin
* In two or more lead ecg ST-segment(the line between QRS complex finish point and the start point of T wave in electrocardiogram) elevation ≥ 0.1mv, or two or more than two neighboring chest lead ST-elevation ≥0.2mv
* Persistent ischemia chest pain less than 6 hours, door to balloon time\>90 minutes and transfer time \>120 minutes
* Accept coronary arteriography and intervention treatment
* Signed informed consent

Exclusion Criteria

* Pregnancy and lactation, menstrual period women
* Blood disease, clotting hemorrhagic disease, any part of active bleeding or bleeding tendency physique
* History of trauma in two months, including biopsy and received surgical operation
* History of the great vessels punctured in two weeks that could not oppression
* History of ischemic or hemorrhagic stroke and cerebrovascular accident
* Cardiac shock,reinfarction again, right ventricular myocardial infarction, history of cardiopulmonary resuscitation (CPR)
* History of PCI or coronary artery bypass grafting(CABG)
* Killip classification level III(a standard of heart function classification) or above, or cardiac mechanical complications such as cardiac rupture
* History of eyeground hemorrhage
* Currently use of therapeutic doses of anticoagulants, such as warfarin, etc
* Uncontrolled hypertension, systolic blood pressure before thrombolysis is still 160 mmHg or higher, diastolic blood pressure is still 100 mmHg or higher
* Active internal bleeding (such as gastrointestinal bleeding), urogenital system, or have not cure of peptic ulcer in four weeks
* Severe liver and kidney dysfunction
* Intracranial tumor, suspicious aortic dissection, arteriovenous malformation, aneurysm
* Thrombolysis treatment in one week
* Allergies of thrombolysis drug or contrast
* Participated in any clinical trials within three months
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Hospital of Jilin University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bin Liu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Second Hospital of Jilin University

Locations

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The second hospital of Jilin university

Changchun, Jilin, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Bin Liu, Doctor

Role: CONTACT

043188796598

Yongfeng Shi, Doctor

Role: CONTACT

043188796625

Facility Contacts

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He Wang, Doctor

Role: primary

043188796625

Other Identifiers

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SecondJilinU-2

Identifier Type: -

Identifier Source: org_study_id

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