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

Sponsor
Xijing Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02592694
Collaborator
(none)
1,000
Enrollment
1
Location
2
Arms
24
Duration (Months)
41.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Intracoronary Cocktail Injection Combined With Thrombus Aspiration in ST-elevation Myocardial Infarction Patients Treated With Primary Angioplasty
Study Start Date :
Oct 1, 2015
Anticipated Primary Completion Date :
Oct 1, 2017
Anticipated Study Completion Date :
Oct 1, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Death, Mayocardial infarction, NYHA Ⅳ heart failure [1 year]

      number of participants with death, mayocardial infarction or NYHA Ⅳ heart failure

    Secondary Outcome Measures

    1. Slow reflow/no reflow [intraoperative]

      number of participants with slow reflow/no reflow during PCI

    2. Left ventricular function [1 year]

      left ventricular ejection fraction evaluated by ultrasound and MRI

    3. Seattle Angina Questionnaire scores [1 year]

      Seattle Angina Questionnaire scores

    4. Canadian Cardiovascular Society (CCS) Functional Angina classification [1 year]

      Canadian Cardiovascular Society (CCS) Functional Angina classification

    5. 6-minute walk distance (6MWD) [1 year]

      6-minute walk distance (6MWD)

    6. Stroke [1 year]

      number of participants with stroke

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xijing hospital Xi'an Shaanxi China 710032

    Sponsors and Collaborators

    • Xijing Hospital

    Investigators

    • Principal Investigator: Dongdong Sun, M.D.,Ph.D., Air Force Military Medical University, China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    sunddong, Principal Investigator, Xijing Hospital
    ClinicalTrials.gov Identifier:
    NCT02592694
    Other Study ID Numbers:
    • Cocktail I
    First Posted:
    Oct 30, 2015
    Last Update Posted:
    Oct 30, 2015
    Last Verified:
    Oct 1, 2015
    Additional relevant MeSH terms:
    Myocardial Infarction
    ST Elevation Myocardial Infarction
    Infarction
    Tenecteplase
    Tirofiban
    Bivalirudin

    Study Results

    No Results Posted as of Oct 30, 2015