NCT02894138

Brief Summary

In this study the investigators test the hypothesis that alteplase given intra coronary after PCI reduce infarct size in patients with ST-elevation myocardial infarction(STEMI) and impaired microvascular function defined as a value of index of microvascular resistance (IMR) \>30.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2016

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

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

August 24, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

5.3 years

First QC Date

August 24, 2016

Last Update Submit

September 3, 2021

Conditions

ST-segment Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Ratio of myocardial infarct size to area at risk assessed by MRI

    MRI performed early (day 2-6) to assess area at risk and late (3 months) to assess infarct size

    3 months

Secondary Outcomes (13)

  • Change of index of microvascular resistance and coronary flow reserve

    Immediately after drug administration during invasive index procedure

  • Degree of microvascular obstruction assessed by MRI

    2-6 days

  • Peak level of Troponin T

    12 hours

  • Level of NtProBNP

    12 hours

  • Non invasive CFR

    3 months

  • +8 more secondary outcomes

Study Arms (3)

Alteplase

EXPERIMENTAL

40 patients: 4-5 minutes of infusion of 10 ml of alteplase 2mg/ml in culprit vessel

Drug: alteplase

Placebo

PLACEBO COMPARATOR

40 patients: 4-5 minutes of infusion of 10 ml of NaCl in culprit vessel

Drug: Placebo

Observational

NO INTERVENTION

10 patients with IMR \<30 will undergo the same follow-up as the randomised patients

Interventions

alteplaseDRUG
Also known as: Actilyse®
Alteplase
PlaceboDRUG
Also known as: NaCl
Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Oral and signed informed consent
  • Males and females 18 - 85 years of age
  • Diagnosis of ST-elevation myocardial infarction (STEMI) including occlusion of culprit vessel on angiography
  • Onset of continuous symptoms within 12 hours
  • Have undergone PCI of culprit vessel
  • Subjects are willing to comply with scheduled visits and tests and are able and willing to provide informed consent

You may not qualify if:

  • Previously known ejection fraction \<30%
  • Previous PCI in the culprit vessel
  • Chronic total occlusion in major vessel
  • Any history of bleeding diathesis, known coagulopathy, or will refuse blood transfusions
  • Recent history or known platelet count \<100.000 cells/mm3 or Hbg \< 10 g/dL
  • Known reduced kidney function with estimated glomerular filtration rate (GFR) \<30 ml/min/1.73m2.
  • Previous hemorrhagic stroke
  • Ongoing oral anticoagulation treatment
  • Severe asthma requiring daily treatment
  • Any mechanical complication (e.g. ventricular septal defect, papillary muscle rupture, cardiac tamponade)
  • Atrioventricular block grade III
  • Known inability to undergo MRI investigation
  • Permanent pacemaker
  • Pronounced claustrophobia
  • Known intolerance to study drug
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

Related Publications (5)

  • Fearon WF, Shah M, Ng M, Brinton T, Wilson A, Tremmel JA, Schnittger I, Lee DP, Vagelos RH, Fitzgerald PJ, Yock PG, Yeung AC. Predictive value of the index of microcirculatory resistance in patients with ST-segment elevation myocardial infarction. J Am Coll Cardiol. 2008 Feb 5;51(5):560-5. doi: 10.1016/j.jacc.2007.08.062.

    PMID: 18237685BACKGROUND

  • Lim HS, Yoon MH, Tahk SJ, Yang HM, Choi BJ, Choi SY, Sheen SS, Hwang GS, Kang SJ, Shin JH. Usefulness of the index of microcirculatory resistance for invasively assessing myocardial viability immediately after primary angioplasty for anterior myocardial infarction. Eur Heart J. 2009 Dec;30(23):2854-60. doi: 10.1093/eurheartj/ehp313. Epub 2009 Aug 14.

    PMID: 19684025BACKGROUND

  • Fearon WF, Low AF, Yong AS, McGeoch R, Berry C, Shah MG, Ho MY, Kim HS, Loh JP, Oldroyd KG. Prognostic value of the Index of Microcirculatory Resistance measured after primary percutaneous coronary intervention. Circulation. 2013 Jun 18;127(24):2436-41. doi: 10.1161/CIRCULATIONAHA.112.000298. Epub 2013 May 16.

    PMID: 23681066BACKGROUND

  • Boscarelli D, Vaquerizo B, Miranda-Guardiola F, Arzamendi D, Tizon H, Sierra G, Delgado G, Fantuzzi A, Estrada D, Garcia-Picart J, Cinca J, Serra A. Intracoronary thrombolysis in patients with ST-segment elevation myocardial infarction presenting with massive intraluminal thrombus and failed aspiration. Eur Heart J Acute Cardiovasc Care. 2014 Sep;3(3):229-36. doi: 10.1177/2048872614527008. Epub 2014 Mar 17.

    PMID: 24637066BACKGROUND

  • Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.

    PMID: 21670242BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBiological Factors

Study Officials

  • Oskar Angerås, MD, PhD

    Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oskar Angerås, MD, PhD

CONTACT

+46703134091oskar.angeras@vgregion.se

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2016

First Posted

September 9, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2021

Study Completion

December 1, 2022

Last Updated

September 5, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)