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

October 28, 2015 updated by: sunddong, Xijing Hospital

Intracoronary Cocktail Injection Combined With Thrombus Aspiration in ST-elevation Myocardial Infarction Patients Treated With Primary Angioplasty

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Xijing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cocktail with thrombus aspiration
Intracoronary cocktail (tirofiban, bivalirudin, tenecteplase) injection combined with thrombus aspiration
Drug: cocktail
Cocktail (tirofiban, bivalirudin, tenecteplase) will be given in addition to thrombus aspiration
Other Names:
  • tirofiban, bivalirudin, tenecteplase
Device: thrombus aspiration
manual thrombus aspiration
Other Names:
  • manual thrombus aspiration
ACTIVE_COMPARATOR: Thrombus aspiration
Thrombus aspiration alone
Device: thrombus aspiration
manual thrombus aspiration
Other Names:
  • manual thrombus aspiration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death, Mayocardial infarction, NYHA Ⅳ heart failure
Time Frame: 1 year
number of participants with death, mayocardial infarction or NYHA Ⅳ heart failure
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seattle Angina Questionnaire scores
Time Frame: 1 year
Seattle Angina Questionnaire scores
1 year
Canadian Cardiovascular Society (CCS) Functional Angina classification
Time Frame: 1 year
Canadian Cardiovascular Society (CCS) Functional Angina classification
1 year
6-minute walk distance (6MWD)
Time Frame: 1 year
6-minute walk distance (6MWD)
1 year
Slow reflow/no reflow
Time Frame: intraoperative
number of participants with slow reflow/no reflow during PCI
intraoperative
Left ventricular function
Time Frame: 1 year
left ventricular ejection fraction evaluated by ultrasound and MRI
1 year
Stroke
Time Frame: 1 year
number of participants with stroke
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ANTICIPATED)

October 1, 2017

Study Completion (ANTICIPATED)

October 1, 2017

Study Registration Dates

First Submitted

October 26, 2015

First Submitted That Met QC Criteria

October 28, 2015

First Posted (ESTIMATE)

October 30, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

October 30, 2015

Last Update Submitted That Met QC Criteria

October 28, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cocktail I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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