DRUG
cocktail
Cocktail (tirofiban, bivalirudin, tenecteplase) will be given in addition to thrombus aspiration
Intracoronary Cocktail Injection Combined With Thrombus Aspiration in STEMI Patients Treated With Primary Angioplasty
Status
Unknown
Phase
Phase 4
Enrollment
1,000
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
DEVICE
thrombus aspiration
manual thrombus aspiration
Timeline
From registration to results.
First posted
Oct 30, 2015
Study start
Oct 2015
Primary completion
Oct 2017
Study completion
Oct 2017
Results posted
Not reported
Registry updated
Oct 30, 2015
Outcomes
What the study measures.
Primary outcomes
Death, Mayocardial infarction, NYHA Ⅳ heart failure
Time frame · 1 year
number of participants with death, mayocardial infarction or NYHA Ⅳ heart failure
Secondary outcomes
Slow reflow/no reflow
Time frame · intraoperative
number of participants with slow reflow/no reflow during PCI
Left ventricular function
Time frame · 1 year
left ventricular ejection fraction evaluated by ultrasound and MRI
Seattle Angina Questionnaire scores
Time frame · 1 year
Seattle Angina Questionnaire scores
Canadian Cardiovascular Society (CCS) Functional Angina classification
Time frame · 1 year
Canadian Cardiovascular Society (CCS) Functional Angina classification
6-minute walk distance (6MWD)
Time frame · 1 year
6-minute walk distance (6MWD)
Stroke
Time frame · 1 year
number of participants with stroke
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Sex
- ALL
- 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
Study locations
1 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
Xijing hospital
Xi'an, Shaanxi, China
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
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