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

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ClinicalTrials.gov Identifier: NCT02592694
Recruitment Status : Unknown
Verified October 2015 by sunddong, Xijing Hospital.
Recruitment status was:  Recruiting
First Posted : October 30, 2015
Last Update Posted : October 30, 2015
Sponsor:
Information provided by (Responsible Party):
sunddong, Xijing Hospital

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
ST-elevation Myocardial Infarction Drug: cocktail Device: thrombus aspiration 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


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 Name: tirofiban, bivalirudin, tenecteplase

Device: thrombus aspiration
manual thrombus aspiration
Other Name: manual thrombus aspiration

Active Comparator: Thrombus aspiration
Thrombus aspiration alone
Device: thrombus aspiration
manual thrombus aspiration
Other Name: manual thrombus aspiration




Primary Outcome Measures :
  1. Death, Mayocardial infarction, NYHA Ⅳ heart failure [ Time Frame: 1 year ]
    number of participants with death, mayocardial infarction or NYHA Ⅳ heart failure


Secondary Outcome Measures :
  1. Slow reflow/no reflow [ Time Frame: intraoperative ]
    number of participants with slow reflow/no reflow during PCI

  2. Left ventricular function [ Time Frame: 1 year ]
    left ventricular ejection fraction evaluated by ultrasound and MRI

  3. Seattle Angina Questionnaire scores [ Time Frame: 1 year ]
    Seattle Angina Questionnaire scores

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

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

  6. Stroke [ Time Frame: 1 year ]
    number of participants with stroke



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592694


Contacts
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Contact: Dongdong Sun, M.D.,Ph.D. 86 29 84775183 wintersun3@gmail.com

Locations
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China, Shaanxi
Xijing hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Dongdong Sun, M.D.,Ph.D    86 18691569930    wintersun3@gmail.com   
Sponsors and Collaborators
Xijing Hospital
Investigators
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Principal Investigator: Dongdong Sun, M.D.,Ph.D. Fourth Military Medical University

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Responsible Party: sunddong, Principal Investigator, Xijing Hospital
ClinicalTrials.gov Identifier: NCT02592694    
Other Study ID Numbers: Cocktail I
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: October 30, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Tirofiban
Tenecteplase
Bivalirudin
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Platelet Aggregation Inhibitors