NCT03753269

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2019

Longer than P75 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 26, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

November 26, 2018

Status Verified

November 1, 2018

Enrollment Period

3 years

First QC Date

November 16, 2018

Last Update Submit

November 23, 2018

Conditions

ST Segment Elevation Myocardial Infarction

Keywords

myocardial infarctionreperfusion therapymicrovascular dysfunctionFasudil Hydrochloridemyocardial perfusion

Outcome Measures

Primary Outcomes (2)

  • 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

    PCI procedure

  • 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)

    Within one week after the STEMI onset

Secondary Outcomes (6)

  • CMR-derived infarction size

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

  • TIMI Flow Grade (TFG)

    PCI procedure

  • TIMI Myocardial Perfusion Grade (TMPG)

    PCI procedure

  • TMPFC

    PCI procedure

  • Complete ST-segment Resolution

    90 minutes after PCI procedure

  • +1 more secondary outcomes

Study Arms (2)

Fasudil Hydrochloride

EXPERIMENTAL

Fasudil Hydrochoride will be delivered into culprit vessel right after the first wire passage

Drug: Fasudil Hydrochloride

Placebo saline

PLACEBO COMPARATOR

Same volume of 0.9% saline will be delivered into culprit vessel right after the first wire passage

Drug: Placebo saline

Interventions

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

Fasudil Hydrochloride
Placebo salineDRUG

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

Placebo saline

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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)
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 19960517BACKGROUND

  • 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.

    PMID: 10637197BACKGROUND

  • 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.

    PMID: 23806080BACKGROUND

  • 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.

    PMID: 25065335BACKGROUND

  • 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.

    PMID: 4038784BACKGROUND

  • 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.

    PMID: 11751708BACKGROUND

  • 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.

    PMID: 9353125BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionMyocardial Infarction

Interventions

fasudil

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Jun Pu, Professor

CONTACT

+86-21-68383164pujun310@hotmail.com

Heng Ge, M.D

CONTACT

dr.geheng@foxmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2018

First Posted

November 26, 2018

Study Start

July 1, 2019

Primary Completion

June 30, 2022

Study Completion

December 30, 2022

Last Updated

November 26, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share