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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03406832
Other study ID # KS-2017-177
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 8, 2018
Est. completion date December 31, 2019

Study information

Verified date June 2019
Source The First Affiliated Hospital of Zhengzhou University
Contact Chunguang Qiu, Phd
Phone +86-13803898806
Email qcg123@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Elective percutaneous coronary intervention (EPCI) is the common treatment of ST segment elevation myocardial infarction (STEMI).Slow flow / no-reflow phenomenon following EPCI in STEMI patients has been a serious and common complication that closely related to the incidence of major adverse cardiovascular events (MACE) and affected patients' prognosis. No reflow is a multi-factorial phenomenon. And its preventive and therapeutic effects are not satisfactory. This prospective randomized controlled study aimed to compare favorable effects of Nitroprusside versus Tirofiban on the prevention of slow flow / no-reflow phenomenon during EPCI.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 31, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Ischemic symptoms < 2 weeks (> 24 hours)

- Continued ischemic chest pain > 30min

- ST-segment elevation = 0.1 millivolt in 2 or more contiguous leads on the 12-lead ECG or new left bundle branch block (LBBB)

- Detection of a rise of cardiac biomarker values with at least one value above the 99th percentile upper reference limit (URL)

- Elective coronary artery angiography was planned.

Exclusion Criteria:

- Emergency thrombolytic therapy was performed before elective coronary artery angiography

- Cardiogenic shock with no response to hypervolemic treatment or vasopressor

- Severe cardiomyopathy or valvular disease requiring intervention

- Coronary ectasia

- Severe heart failure

- Contraindication or allergy to antiplatelet drugs

- Contraindication or allergy to experimental drugs

- Unable to receive at least 1 year of dual antiplatelet therapy

- Active bleeding or extreme-risk for major bleeding

- Severe liver or renal failure

- Life expectancy < 1 year

- Unable or unwilling to provide informed consent

- Women of child bearing potential

- Under 18 years of age

- Hemoglobin < 90g/L

- Platelet count < 100×10^9/L

- Can not cooperate (with mental disorders or cognitive disorders)

Study Design


Related Conditions & MeSH terms

  • Elective Percutaneous Coronary Intervention
  • Infarction
  • Myocardial Infarction
  • ST Elevation Myocardial Infarction
  • ST Segment Elevation Myocardial Infarction

Intervention

Drug:
Nitroprusside Sodium
Intracoronary infusion 50~100µg each time (repeated)
Tirofiban Hydrochloride
Intracoronary infusion 10µg/kg for single time
Heparinized saline
Intracoronary infusion 2ml for single time

Locations

Country Name City State
China Anyang District Hospital Anyang Henan
China The 99th Central Hospital of the People's Liberation Army Jiaozuo Henan
China The People's Hospital of Jiaozuo Jiaozuo Henan
China Jincheng People's Hospital Jincheng Shanxi
China The second people's Hospital of Jiyuan Jiyuan Henan
China Huaihe Hospital of Henan University Kaifeng Henan
China Kaifeng Central Hospital Kaifeng Henan
China The First Affiliated Hospital of Henan University of Science and Technology Luoyang Henan
China Lushan People's Hospital Lushan Henan
China Nanyang City Center Hospital Nanyang Henan
China Pingmei Shenma Medical Group General Hospital Pingdingshan Henan
China The Second People's Hospital of Pingdingshan Pingdingshan Henan
China Puyang Oilfield General Hospital Puyang Henan
China Puyang People's Hospital Puyang Henan
China Yellow River Sanmenxia hospital Sanmenxia Henan
China The First People's Hospital of Shangqiu Shangqiu Henan
China The First Affiliated Hospital of Xinxiang Medical University Xinxiang Henan
China Xinyang Central Hospital Xinyang Henan
China Yanshi People's Hospital Yanshi Henan
China People's Hospital of Zhengzhou Zhengzhou Henan
China The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan
China The First People's Hospital of Xinmi Zhengzhou Henan
China Zhengzhou Cardiovascular Hospital Zhengzhou Henan
China Zhengzhou Central Hospital Zhengzhou Henan
China Zhengzhou First People's Hospital Zhengzhou Henan
China Zhoukou Central Hospital Zhoukou Henan
China The First People's Hospital of Zhumadian Zhumadian Henan
China Zhumadian Central Hospital Zhumadian Henan

Sponsors (28)

Lead Sponsor Collaborator
The First Affiliated Hospital of Zhengzhou University Anyang Regional Hospital, First Affiliated Hospital of Xinjiang Medical University, Huaihe Hospital of Henan University, Jincheng People’s Hospital, Kaifeng Central Hospital, Lushan People’s Hospital, Nanyang Central Hospital, People's Hospital of Zhengzhou University, Puyang Oil Field General Hospital, Puyang People's Hospital, Shenma Medical Group General Hospital, The 99th Central Hospital of the People's Liberation Army, The First Affiliated Hospital of Henan University of Science and Technology, The First People's Hospital of Shangqiu, The First People's Hospital of Xinmi, The First People's Hospital of Zhumadian, The Peoples' Hospital of Jiaozuo City, The second people's Hospital of Jiyuan, The Second People's Hospital of Pingdingshan, Xinyang Central Hospital, Yanshi People’s Hospital, Yellow River Sanmenxia hospital, Zhengzhou Cardiovascular Hospital, Zhengzhou Central Hospital, Zhengzhou First People’s Hospital, Zhoukou Central Hospital, Zhumadian Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Coronary artery flow using thrombolysis in myocardial infarction (TIMI) flow grade grade 0, no myocardial blush or contrast density; grade 1, minimal myocardial blush or contrast density; grade 2, moderate myocardial blush or contrast density but less than that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery; grade 3, normal myocardial blush or contrast density comparable with that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery. 1 minute after stent implantation; 1 minute after balloon dilatation
Primary Coronary TIMI frame count A continuous measurement assessing flow in the epicardial arteries. 1 minute after stent implantation; 1 minute after balloon dilatation
Primary Slow flow / no-reflow phenomenon Slow flow phenomenon means delayed progression or lack of contrast medium through the coronary tree. 1 minute after stent implantation; 1 minute after balloon dilatation
Secondary Main adverse cardiovascular and cerebrovascular events (MACCE) Death, Cardiac death, Rehospitalization (Heart failure) , Non-fatal myocardial infarction, Target vessel myocardial infarction, Target lesion revascularization, Target vessel revascularization, Ischemic-driven revascularization, Stent thrombosis, Bleeding, Cerebrovascular events, etc. at 1 day post-PCI, at follow up of 1, 3, 6,12 months post-PCI
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