Prevention of Coronary Slow Flow or No-Reflow During EPCI in Patients With Acute STEMI

NCT ID: NCT03406832

Last Updated: 2019-06-07

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

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-08

Study Completion Date

2019-12-31

Brief Summary

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Elective percutaneous coronary intervention (EPCI) is the common treatment of ST segment elevation myocardial infarction (STEMI).Slow flow / no-reflow phenomenon following EPCI in STEMI patients has been a serious and common complication that closely related to the incidence of major adverse cardiovascular events (MACE) and affected patients' prognosis. No reflow is a multi-factorial phenomenon. And its preventive and therapeutic effects are not satisfactory. This prospective randomized controlled study aimed to compare favorable effects of Nitroprusside versus Tirofiban on the prevention of slow flow / no-reflow phenomenon during EPCI.

Detailed Description

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Conditions

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ST Segment Elevation Myocardial Infarction Elective Percutaneous Coronary Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Nitroprusside group

After coronary target vessel blood flow recovery by thrombus aspiration or/and balloon angioplasty (diameter ≤ 2.0mm), intracoronary infusion of Nitroprusside Sodium via guide-catheter was performed. Then repeated administration of Nitroprusside Sodium was done prior to coronary stent implantation or post dilatation.

Group Type EXPERIMENTAL

Nitroprusside Sodium

Intervention Type DRUG

Intracoronary infusion 50\~100μg each time (repeated)

Tirofiban group

After coronary target vessel blood flow recovery by thrombus aspiration or/and balloon angioplasty (diameter ≤ 2.0mm), intracoronary infusion of Tirofiban Hydrochloride via guide-catheter was performed.

Group Type EXPERIMENTAL

Tirofiban Hydrochloride

Intervention Type DRUG

Intracoronary infusion 10μg/kg for single time

Control group

After coronary target vessel blood flow recovery by thrombus aspiration or/and balloon angioplasty (diameter ≤ 2.0mm), intracoronary infusion of heparinized saline via guide-catheter was performed.

Group Type PLACEBO_COMPARATOR

Heparinized saline

Intervention Type DRUG

Intracoronary infusion 2ml for single time

Interventions

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Nitroprusside Sodium

Intracoronary infusion 50\~100μg each time (repeated)

Intervention Type DRUG

Tirofiban Hydrochloride

Intracoronary infusion 10μg/kg for single time

Intervention Type DRUG

Heparinized saline

Intracoronary infusion 2ml for single time

Intervention Type DRUG

Other Intervention Names

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Experimental-1 group Experimental-2 group Control group

Eligibility Criteria

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Inclusion Criteria

* Ischemic symptoms \< 2 weeks (\> 24 hours)
* Continued ischemic chest pain \> 30min
* ST-segment elevation ≥ 0.1 millivolt in 2 or more contiguous leads on the 12-lead ECG or new left bundle branch block (LBBB)
* Detection of a rise of cardiac biomarker values with at least one value above the 99th percentile upper reference limit (URL)
* Elective coronary artery angiography was planned.

Exclusion Criteria

* Emergency thrombolytic therapy was performed before elective coronary artery angiography
* Cardiogenic shock with no response to hypervolemic treatment or vasopressor
* Severe cardiomyopathy or valvular disease requiring intervention
* Coronary ectasia
* Severe heart failure
* Contraindication or allergy to antiplatelet drugs
* Contraindication or allergy to experimental drugs
* Unable to receive at least 1 year of dual antiplatelet therapy
* Active bleeding or extreme-risk for major bleeding
* Severe liver or renal failure
* Life expectancy \< 1 year
* Unable or unwilling to provide informed consent
* Women of child bearing potential
* Under 18 years of age
* Hemoglobin \< 90g/L
* Platelet count \< 100×10\^9/L
* Can not cooperate (with mental disorders or cognitive disorders)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anyang Regional Hospital

OTHER

Sponsor Role collaborator

Huaihe Hospital of Henan University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Henan University of Science and Technology

OTHER

Sponsor Role collaborator

Yellow River Sanmenxia hospital

UNKNOWN

Sponsor Role collaborator

The Peoples' Hospital of Jiaozuo City

OTHER

Sponsor Role collaborator

Jincheng People's Hospital

OTHER

Sponsor Role collaborator

The second people's Hospital of Jiyuan

UNKNOWN

Sponsor Role collaborator

Kaifeng Central Hospital

OTHER

Sponsor Role collaborator

Lushan People's Hospital

UNKNOWN

Sponsor Role collaborator

Nanyang Central Hospital

OTHER

Sponsor Role collaborator

The Second People's Hospital of Pingdingshan

UNKNOWN

Sponsor Role collaborator

Shenma Medical Group General Hospital

OTHER

Sponsor Role collaborator

Puyang People's Hospital

UNKNOWN

Sponsor Role collaborator

Puyang Oilfield General Hospital

OTHER

Sponsor Role collaborator

The First People's Hospital of Shangqiu

UNKNOWN

Sponsor Role collaborator

Yanshi People's Hospital

UNKNOWN

Sponsor Role collaborator

The First People's Hospital of Xinmi

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital of Xinjiang Medical University

OTHER

Sponsor Role collaborator

Xinyang Central Hospital

OTHER

Sponsor Role collaborator

People's Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Zhengzhou First People's Hospital

UNKNOWN

Sponsor Role collaborator

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role collaborator

Zhengzhou Central Hospital

OTHER

Sponsor Role collaborator

The 99th Central Hospital of the People's Liberation Army

UNKNOWN

Sponsor Role collaborator

Zhoukou Central Hospital

OTHER

Sponsor Role collaborator

The First People's Hospital of Zhumadian

UNKNOWN

Sponsor Role collaborator

Zhumadian Central Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role lead

Responsible Party

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Chunguang Qiu

Director of the Department of Cardiovascular Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chunguang Qiu, Phd

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Zhengzhou University

Locations

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Anyang District Hospital

Anyang, Henan, China

Site Status RECRUITING

The 99th Central Hospital of the People's Liberation Army

Jiaozuo, Henan, China

Site Status RECRUITING

The People's Hospital of Jiaozuo

Jiaozuo, Henan, China

Site Status RECRUITING

The second people's Hospital of Jiyuan

Jiyuan, Henan, China

Site Status RECRUITING

Huaihe Hospital of Henan University

Kaifeng, Henan, China

Site Status RECRUITING

Kaifeng Central Hospital

Kaifeng, Henan, China

Site Status RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Site Status RECRUITING

Lushan People's Hospital

Luyang, Henan, China

Site Status RECRUITING

Nanyang City Center Hospital

Nanyang, Henan, China

Site Status RECRUITING

Pingmei Shenma Medical Group General Hospital

Pingdingshan, Henan, China

Site Status RECRUITING

The Second People's Hospital of Pingdingshan

Pingdingshan, Henan, China

Site Status RECRUITING

Puyang Oilfield General Hospital

Puyang, Henan, China

Site Status RECRUITING

Puyang People's Hospital

Puyang, Henan, China

Site Status RECRUITING

Yellow River Sanmenxia hospital

Sanmenxia, Henan, China

Site Status RECRUITING

The First People's Hospital of Shangqiu

Shangqiu, Henan, China

Site Status RECRUITING

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Site Status RECRUITING

Xinyang Central Hospital

Xinyang, Henan, China

Site Status RECRUITING

Yanshi People's Hospital

Yanshi, Henan, China

Site Status RECRUITING

Zhengzhou First People's Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

Zhengzhou Cardiovascular Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

Zhengzhou Central Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status RECRUITING

People's Hospital of Zhengzhou

Zhengzhou, Henan, China

Site Status RECRUITING

The First People's Hospital of Xinmi

Zhengzhou, Henan, China

Site Status RECRUITING

Zhoukou Central Hospital

Zhoukou, Henan, China

Site Status RECRUITING

The First People's Hospital of Zhumadian

Zhumadian, Henan, China

Site Status RECRUITING

Zhumadian Central Hospital

Zhumadian, Henan, China

Site Status RECRUITING

Jincheng People's Hospital

Jincheng, Shanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chunguang Qiu, Phd

Role: CONTACT

+86-13803898806

Liang Pan, MD

Role: CONTACT

+86-15003851743

Facility Contacts

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Chunguang Qiu, Phd

Role: primary

Other Identifiers

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KS-2017-177

Identifier Type: -

Identifier Source: org_study_id

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