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Intracoronary Cocktail Injection Combined With Thrombus Aspiration in STEMI Patients Treated With Primary Angioplasty

NCT ID: NCT02592694

Last Updated: 2015-10-30

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

PHASE4

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-10-31

Brief Summary

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This is a randomized, double blind, placebo controlled study of intracoronary cocktail injection combined with thrombus aspiration versus thrombus aspiration alone in ST-elevation myocardial infarction patients treated with primary angioplasty.

Detailed Description

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This is a randomized, double blind, placebo controlled study of intracoronary cocktail injection combined with thrombus aspiration versus thrombus aspiration alone in ST-elevation myocardial infarction patients treated with primary angioplasty. Patients with STEMI will be randomized into the cocktail group or the control group. Patients in the cocktail group will receive cocktail injection combined with thrombus aspiration. Patients in the control group will receive thrombus aspiration alone. The primary outcome of the cocktail I study is the composite of death, myocardial infarction or class IV heart failure within 1 year. The secondary outcome of the cocktail I study include slow reflow/no reflow during PCI, left ventricular function, quality of life, stroke or life-threatening bleeding within 1 year.

Conditions

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ST-elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Cocktail with thrombus aspiration

Intracoronary cocktail (tirofiban, bivalirudin, tenecteplase) injection combined with thrombus aspiration

Group Type EXPERIMENTAL

cocktail

Intervention Type DRUG

Cocktail (tirofiban, bivalirudin, tenecteplase) will be given in addition to thrombus aspiration

thrombus aspiration

Intervention Type DEVICE

manual thrombus aspiration

Thrombus aspiration

Thrombus aspiration alone

Group Type ACTIVE_COMPARATOR

thrombus aspiration

Intervention Type DEVICE

manual thrombus aspiration

Interventions

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cocktail

Cocktail (tirofiban, bivalirudin, tenecteplase) will be given in addition to thrombus aspiration

Intervention Type DRUG

thrombus aspiration

manual thrombus aspiration

Intervention Type DEVICE

Other Intervention Names

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tirofiban, bivalirudin, tenecteplase manual thrombus aspiration

Eligibility Criteria

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Inclusion Criteria

* 18-80 years of age adult patients with STEMI Referred for primary PCI within 5d of symptom onset

Exclusion Criteria

* Patients who had undergone previous coronary artery bypass surgery or PCI or had received fibrinolytic therapy History of stroke Active bleeding Severe hepatic or renal dysfunction Cardiogenic shock Contraindications for primary PCI or DAPT
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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sunddong

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dongdong Sun, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Air Force Military Medical University, China

Locations

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Xijing hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dongdong Sun, M.D.,Ph.D.

Role: CONTACT

Phone: 86 29 84775183

Email: [email protected]

Facility Contacts

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Dongdong Sun, M.D.,Ph.D

Role: primary

Other Identifiers

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Cocktail I

Identifier Type: -

Identifier Source: org_study_id