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ST Segment Elevation Myocardial InfarctionNOSLOWFLOW-ⅡNCT03406832

Prevention of Coronary Slow Flow or No-Reflow During EPCI in Patients With Acute STEMI

A study testing Nitroprusside Sodium, Tirofiban Hydrochloride and Heparinized saline in people with ST Segment Elevation Myocardial Infarction and Elective Percutaneous Coronary Intervention, run by The First Affiliated Hospital of Zhengzhou University at 28 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nitroprusside Sodium, Tirofiban Hydrochloride and Heparinized saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,000 participants
Where
28 sitesChina
Study dates
8 Jan 2018to 31 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 17Show fewer
  • 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)

Trial locations and contacts

28 sites in 1 country.

Chunguang Qiu, Phd contact

+86-13803898806

qcg123@163.com

Liang Pan, MD contact

+86-15003851743

huzhoupanliang@gmail.com

28 sites in 1 country

China28 sites, 28 recruiting

  • Anyang District Hospital

    Anyang, Henan, 455000

    Recruiting

  • The 99th Central Hospital of the People's Liberation Army

    Jiaozuo, Henan, 454000

    Recruiting

  • The People's Hospital of Jiaozuo

    Jiaozuo, Henan, 454002

    Recruiting

  • Jincheng People's Hospital

    Jincheng, Shanxi, 048026

    Recruiting

  • The second people's Hospital of Jiyuan

    Jiyuan, Henan, 454000

    Recruiting

  • Huaihe Hospital of Henan University

    Kaifeng, Henan, 475000

    Recruiting

  • Kaifeng Central Hospital

    Kaifeng, Henan, 475000

    Recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471003

    Recruiting

  • Lushan People's Hospital

    Lushan, Henan, 467300

    Recruiting

  • Nanyang City Center Hospital

    Nanyang, Henan, 473000

    Recruiting

  • Pingmei Shenma Medical Group General Hospital

    Pingdingshan, Henan, 467000

    Recruiting

  • The Second People's Hospital of Pingdingshan

    Pingdingshan, Henan, 467000

    Recruiting

  • Puyang Oilfield General Hospital

    Puyang, Henan, 457000

    Recruiting

  • Puyang People's Hospital

    Puyang, Henan, 457099

    Recruiting

  • Yellow River Sanmenxia hospital

    Sanmenxia, Henan, 472000

    Recruiting

  • The First People's Hospital of Shangqiu

    Shangqiu, Henan, 476000

    Recruiting

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan, 453100

    Recruiting

  • Xinyang Central Hospital

    Xinyang, Henan, 464000

    Recruiting

  • Yanshi People's Hospital

    Yanshi, Henan, 471900

    Recruiting

  • Zhengzhou First People's Hospital

    Zhengzhou, Henan, 450004

    Recruiting

  • Zhengzhou Cardiovascular Hospital

    Zhengzhou, Henan, 450006

    Recruiting

  • Zhengzhou Central Hospital

    Zhengzhou, Henan, 450007

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Chunguang Qiu, Phd

    Recruiting

  • People's Hospital of Zhengzhou

    Zhengzhou, Henan, 450053

    Recruiting

  • The First People's Hospital of Xinmi

    Zhengzhou, Henan, 452370

    Recruiting

  • Zhoukou Central Hospital

    Zhoukou, Henan, 466000

    Recruiting

  • The First People's Hospital of Zhumadian

    Zhumadian, Henan, 463000

    Recruiting

  • Zhumadian Central Hospital

    Zhumadian, Henan, 463000

    Recruiting

Other trials in China

About this study

Official title: Prevention of Coronary Slow Flow or No-Reflow During Elective Percutaneous Coronary Intervention in Patients With Acute ST-segment Elevation Myocardial Infarction

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.

Being tested
Nitroprusside Sodium, Tirofiban Hydrochloride, Heparinized saline
Keywords
Prevention, Slow flow, No reflow, Nitroprusside, Tirofiban
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nitroprusside SodiumDrug

    Also called Experimental-1 group

    Intracoronary infusion 50~100μg each time (repeated)

  • Tirofiban HydrochlorideDrug

    Also called Experimental-2 group

    Intracoronary infusion 10μg/kg for single time

  • Heparinized salineDrug

    Also called Control group

    Intracoronary infusion 2ml for single time

Study groups in NCT03406832
Study groupRoleWhat they receive
Nitroprusside groupExperimentalAfter coronary target vessel blood flow recovery by thrombus aspiration or/and balloon angioplasty (diameter ≤ 2.0mm), intracoronary infusion of Nitroprusside Sodium via guide-catheter was performed. Then repeated administration of Nitroprusside Sodium was done prior to coronary stent implantation or post dilatation.
Receives: Drug: Nitroprusside Sodium
Tirofiban groupExperimentalAfter coronary target vessel blood flow recovery by thrombus aspiration or/and balloon angioplasty (diameter ≤ 2.0mm), intracoronary infusion of Tirofiban Hydrochloride via guide-catheter was performed.
Receives: Drug: Tirofiban Hydrochloride
Control groupPlacebo comparatorAfter coronary target vessel blood flow recovery by thrombus aspiration or/and balloon angioplasty (diameter ≤ 2.0mm), intracoronary infusion of heparinized saline via guide-catheter was performed.
Receives: Drug: Heparinized saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 minute after stent implantation; 1 minute after balloon dilatation

  2. Coronary TIMI frame count

    A continuous measurement assessing flow in the epicardial arteries.

    Measured: 1 minute after stent implantation; 1 minute after balloon dilatation

  3. Slow flow / no-reflow phenomenon

    Slow flow phenomenon means delayed progression or lack of contrast medium through the coronary tree.

    Measured: 1 minute after stent implantation; 1 minute after balloon dilatation

Secondary outcomes (1)

  1. 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.

    Measured: at 1 day post-PCI, at follow up of 1, 3, 6,12 months post-PCI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2018
  2. Study start8 Jan 2018
  3. Primary completion30 Jun 2019 (estimated)
  4. Study completion31 Dec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03406832
Sponsor's protocol ID
KS-2017-177
Acronym
NOSLOWFLOW-Ⅱ
Status last verified
Jun 2019
First submitted
8 Jan 2018
Last updated
7 Jun 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Nitroprusside Sodium, Tirofiban Hydrochloride and Heparinized saline in people with ST Segment Elevation Myocardial Infarction and Elective Percutaneous Coronary Intervention, run by The First Affiliated Hospital of Zhengzhou University at 28 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chunguang Qiu, Phd (+86-13803898806, qcg123@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Coronary artery flow using thrombolysis in myocardial infarction (TIMI) flow grade (time frame: 1 minute after stent implantation; 1 minute after balloon dilatation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03406832.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2019.

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