AzTrials
AzTrials

ST Segment Elevation Myocardial InfarctionPhase 4NCT03753269

Early Intracoronary Administration of Fasudil in the Primary PCI of ST-segment-Elevation Myocardial Infarction

A Phase 4 study testing Fasudil Hydrochloride in people with ST Segment Elevation Myocardial Infarction, run by RenJi Hospital.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Trial summary

The study aims to evaluate whether an early intracoronary administration of Fasudil Hydrochloride during primary PCI of STEMI can improve epicardial and myocardial perfusion as well as clinical outcomes. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Fasudil Hydrochloride
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
600 participants
Where
No sites listed yet
Study dates
1 Jul 2019to 30 Dec 2022
Phase
Phase 4
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: over 18 or 18 years old, less than 75 years old;
  • Patents with myocardial infarction who have symptom onset within 6h before randomization;
  • ECG: ≥2 mm ST-segment elevation in 2 contiguous precordial leads or ≥1 mm ST-segment elevation in 2 contiguous extremity leads ;
  • Signed informed consent form prior to trial participation
  • Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 7 days;
  • Pregnancy or lactating;
Show all 9Show fewer
  • Body weight <40kg or >125kg;
  • Known allergy to any drug that may appear in the study
  • Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk.

Who cannot join

  • ECG with new left bundle branch block;
  • Contraindications for CMR
  • Repeated STEMI
  • History of cardiovascular diseases
  • PCI within previous 1 month or Previous coronary-artery bypass surgery (CABG)
  • Previously known multi-vessel coronary artery disease not suitable for revascularization
Show all 16Show fewer
  • Hospitalization for cardiac reason within past 48 hours
  • Known acute pericarditis and/or subacute bacterial endocarditis
  • Arterial aneurysm, arterial/venous malformation and aorta dissection;
  • History of other severe diseases
  • Any other diseases with life expectancy ≤12 months
  • • Any history of severe renal or hepatic dysfunction (hepatic failure, cirrhosis, portal hypertension and active hepatitis); Neutropenia, thrombocytopenia; Known acute pancreatitis
  • Severe cardiac complications
  • Any sign of cardiac rupture
  • Cardiogenic shock (SBP <90 mmHg after fluid infusion or SBP<100 mmHg after vasoactive drugs)
  • Not suitable for clinical trial

Trial locations and contacts

No sites are listed yet.

Jun Pu, Professor contact

+86-21-68383164

pujun310@hotmail.com

Heng Ge, M.D contact

dr.geheng@foxmail.com

About this study

Official title: Efficacy of Early Intracoronary Administration of Fasudil Hydrochloride on Myocardial Perfusion in the Primary PCI of ST-elevation Myocardial Infarction: an Prospective, Randomized and Multicenter Trial

The study aims to evaluate whether an early intracoronary administration of Fasudil Hydrochloride during primary PCI of STEMI can improve epicardial and myocardial perfusion as well as clinical outcomes.

Read the detailed description

Timely reperfusion therapy is the most effective treatment for acute STEMI patients. Primary PCI has been documented as the best method for restoration of epicardial blood flow. Nevertheless, recovery of epicardial blood flow does not necessarily equate to a sufficient reperfusion at myocardial level. Although epicardial TIMI 3 flow could be achieved in the majority of STEMI patients by contemporary PPCI, it has been well acknowledged that microvascular obstruction (MVO) is far more prevalent than the epicardial no-reflow phenomenon and has huge detrimental impact on clinical outcomes.

Routine thrombus aspiration by special catheter during primary PCI has shown negative or even harmful results in clinical trials. Distal coronary protective devices are also ineffective to improve myocardial perfusion. On the contrary, peri-procedual administration of several medications has shown possibilities to reduce MVO. These medications are mostly anti-platelet agents such as GP IIb/IIIa receptor and microvascular dilators like adenosine, sodium nitroprusside and verapamil. Theoretically, intracoronary delivery of medications can be more effective and potentially decrease side effects. Empirical application of aforementioned agents seems to improve the epicardial flow in patients not achieving TIMI 3 flow after PCI. However, it is debatable whether early administration of intracoronary medication (meaning before PCI) may further reduce MVO assuming it could be better to reduce reperfusion injury. However, this has not been well investigated yet.

Rho-associated protein kinase (Rho kinase) is expressed in many cells, including smooth muscle cells and vascular endothelial. Activation of Rho kinase leads to increased smooth muscle intracellular calcium and robust vasoconstriction. Fasudil hydrochloride is a rho-kinase inhibitor that severs clinically as a potent small vessel dilator, especially in the field of cerebral circulation. Meanwhile, It has been empirically used in individual STEMI cases and showed effectiveness in improving coronary flow for PCI therapy. This study aims to evaluate whether an early intracoronary administration of Fasudil Hydrochloride can improve myocardial perfusion and clinical outcomes for STEMI patients undergoing primary PCI. To ensure the complete delivery of agents within coronary, a special-designed targeted perfusion micro-catheter will be used for drug delivery. Patients in the control arm will be administrated by intracoronary saline.

For the results, coronary angiography-based index of epical and myocardial perfusion will be analyzed. MVO will be determined by cardiac magnetic resonance imaging and quantified as the percentage of left ventricular myocardial mass (% LV). The rate of composite major adverse cardiac events (MACEs) at 30 days and 6 months since symptom onset will be the clinical outcomes.

Being tested
Fasudil Hydrochloride, Placebo saline
Keywords
myocardial infarction, reperfusion therapy, microvascular dysfunction, Fasudil Hydrochloride, myocardial perfusion
Medical subject headings
ST Elevation Myocardial Infarction, Myocardial Infarction

What participants receive

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

  • Fasudil HydrochlorideDrug

    2.5mg fasudil hydrochloride (diulted to 15ml by 0.9% saline )will be delivered by targeted perfusion micro-catheter into culprit vessel right after the first wire passage

  • Placebo salineDrug

    15ml 0.9% saline will be delivered by targeted perfusion micro-catheter into culprit vessel right after the first wire passage

Study groups in NCT03753269
Study groupRoleWhat they receive
Fasudil HydrochlorideExperimentalFasudil Hydrochoride will be delivered into culprit vessel right after the first wire passage
Receives: Drug: Fasudil Hydrochloride
Placebo salinePlacebo comparatorSame volume of 0.9% saline will be delivered into culprit vessel right after the first wire passage
Receives: Drug: Placebo saline

What is being measured

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

  1. Complete epicardial and myocardial reperfusion after PCI

    The percentage of patient achieving both thrombolysis in myocardial infarction (TIMI) flow grade (TFG) 3 for epicardial reperfusion and TIMI myocardial perfusion (TMPG) grade 3 for myocardial reperfusion

    Measured: PCI procedure

  2. CMR-derived microvascular obstruction (MVO)

    MVO is defined as hypoenhanced area within infracted zone presented by CMR gadolinium late enhancement imaging. MVO will be quantified as the percentage of LV mass (% LV)

    Measured: Within one week after the STEMI onset

Secondary outcomes (6)

  1. CMR-derived infarction size

    Infarct size was determined by the extent of late gadolinium enhancement on CMR and expressed as a percentage of LV mass (% LV)

    Measured: Within one week of STEMI onset, repeated on the sixth month

  2. TIMI Flow Grade (TFG)

    Percentage of patients achieving TFG 3

    Measured: PCI procedure

  3. TIMI Myocardial Perfusion Grade (TMPG)

    Percentage of patients achieving TMPG 3

    Measured: PCI procedure

  4. TMPFC

    Mean or median value of TMPFC

    Measured: PCI procedure

  5. Complete ST-segment Resolution

    Percentage of patients achieving ≥ 70% resolution of the initial sum of ST-segment elevation

    Measured: 90 minutes after PCI procedure

  6. MACEs

    Incidence of major adverse cardiac events (MACEs) as a composite of all cause death, nonfatal reinfarction, heart failure and stroke after PCI

    Measured: 30 days and 6 months after STEMI onset

Timeline

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

  1. First posted26 Nov 2018
  2. Study start1 Jul 2019 (estimated)
  3. Primary completion30 Jun 2022 (estimated)
  4. Study completion30 Dec 2022 (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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03753269
Sponsor's protocol ID
EARLY-MYO-FASUDIL
Status last verified
Nov 2018
First submitted
16 Nov 2018
Last updated
26 Nov 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ding S, Pu J, Qiao ZQ, Shan P, Song W, Du Y, Shen JY, Jin SX, Sun Y, Shen L, Lim YL, He B. TIMI myocardial perfusion frame count: a new method to assess myocardial perfusion and its predictive value for short-term prognosis. Catheter Cardiovasc Interv. 2010 Apr 1;75(5):722-32. doi: 10.1002/ccd.22298.

    PubMed 19960517

  • Gibson CM, Cannon CP, Murphy SA, Ryan KA, Mesley R, Marble SJ, McCabe CH, Van De Werf F, Braunwald E. Relationship of TIMI myocardial perfusion grade to mortality after administration of thrombolytic drugs. Circulation. 2000 Jan 18;101(2):125-30. doi: 10.1161/01.cir.101.2.125.

    PubMed 10637197

  • Kidambi A, Mather AN, Motwani M, Swoboda P, Uddin A, Greenwood JP, Plein S. The effect of microvascular obstruction and intramyocardial hemorrhage on contractile recovery in reperfused myocardial infarction: insights from cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2013 Jun 27;15(1):58. doi: 10.1186/1532-429X-15-58.

    PubMed 23806080

  • Taniguchi Y, Funayama H, Matsuda J, Fujita K, Nakagawa T, Nakamura T, Umemoto T, Mitsuhashi T, Ako J, Momomura S. Super-selective intracoronary injection of Rho-kinase inhibitor relieves refractory coronary vasospasms: a case report. Int J Cardiol. 2014 Sep;176(1):270-1. doi: 10.1016/j.ijcard.2014.06.096. Epub 2014 Jul 8. No abstract available.

    PubMed 25065335

  • TIMI Study Group. The Thrombolysis in Myocardial Infarction (TIMI) trial. Phase I findings. N Engl J Med. 1985 Apr 4;312(14):932-6. doi: 10.1056/NEJM198504043121437. No abstract available.

    PubMed 4038784

  • Masumoto A, Hirooka Y, Shimokawa H, Hironaga K, Setoguchi S, Takeshita A. Possible involvement of Rho-kinase in the pathogenesis of hypertension in humans. Hypertension. 2001 Dec 1;38(6):1307-10. doi: 10.1161/hy1201.096541.

    PubMed 11751708

  • Uehata M, Ishizaki T, Satoh H, Ono T, Kawahara T, Morishita T, Tamakawa H, Yamagami K, Inui J, Maekawa M, Narumiya S. Calcium sensitization of smooth muscle mediated by a Rho-associated protein kinase in hypertension. Nature. 1997 Oct 30;389(6654):990-4. doi: 10.1038/40187.

    PubMed 9353125

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fasudil Hydrochloride in people with ST Segment Elevation Myocardial Infarction, run by RenJi Hospital.

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 9 inclusion and 16 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 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Jun Pu, Professor (+86-21-68383164, pujun310@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete epicardial and myocardial reperfusion after PCI (time frame: PCI procedure). The study lists 2 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 NCT03753269, which also lists 7 linked publications.

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 26 Nov 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in