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

Primary Purpose

ST-elevation Myocardial Infarction

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
cocktail
thrombus aspiration
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST-elevation Myocardial Infarction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Xijing hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cocktail with thrombus aspiration

Thrombus aspiration

Arm Description

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

Thrombus aspiration alone

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 26, 2015
Last Updated
October 28, 2015
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02592694
Brief Title
Intracoronary Cocktail Injection Combined With Thrombus Aspiration in STEMI Patients Treated With Primary Angioplasty
Official Title
Intracoronary Cocktail Injection Combined With Thrombus Aspiration in ST-elevation Myocardial Infarction Patients Treated With Primary Angioplasty
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-elevation Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cocktail with thrombus aspiration
Arm Type
Experimental
Arm Description
Intracoronary cocktail (tirofiban, bivalirudin, tenecteplase) injection combined with thrombus aspiration
Arm Title
Thrombus aspiration
Arm Type
Active Comparator
Arm Description
Thrombus aspiration alone
Intervention Type
Drug
Intervention Name(s)
cocktail
Other Intervention Name(s)
tirofiban, bivalirudin, tenecteplase
Intervention Description
Cocktail (tirofiban, bivalirudin, tenecteplase) will be given in addition to thrombus aspiration
Intervention Type
Device
Intervention Name(s)
thrombus aspiration
Other Intervention Name(s)
manual thrombus aspiration
Intervention Description
manual thrombus aspiration
Primary Outcome Measure Information:
Title
Death, Mayocardial infarction, NYHA Ⅳ heart failure
Description
number of participants with death, mayocardial infarction or NYHA Ⅳ heart failure
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Slow reflow/no reflow
Description
number of participants with slow reflow/no reflow during PCI
Time Frame
intraoperative
Title
Left ventricular function
Description
left ventricular ejection fraction evaluated by ultrasound and MRI
Time Frame
1 year
Title
Seattle Angina Questionnaire scores
Description
Seattle Angina Questionnaire scores
Time Frame
1 year
Title
Canadian Cardiovascular Society (CCS) Functional Angina classification
Description
Canadian Cardiovascular Society (CCS) Functional Angina classification
Time Frame
1 year
Title
6-minute walk distance (6MWD)
Description
6-minute walk distance (6MWD)
Time Frame
1 year
Title
Stroke
Description
number of participants with stroke
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dongdong Sun, M.D.,Ph.D.
Phone
86 29 84775183
Email
wintersun3@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dongdong Sun, M.D.,Ph.D.
Organizational Affiliation
Air Force Military Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xijing hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongdong Sun, M.D.,Ph.D
Phone
86 18691569930
Email
wintersun3@gmail.com

12. IPD Sharing Statement

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

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