NCT00502528

Brief Summary

Background and Objective: Acute coronary syndrome is characterized by compromised blood flow at the epicardial and microvascular levels. The aim of the present study is to investigate the effect of ET-receptor blockade by BQ-123 on myocardial perfusion and infarct size as an adjunct to PCI-reperfusion therapy in patients with STEMI. Patients are randomized to receive periinterventional intravenous BQ-123 or placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 17, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

April 30, 2013

Status Verified

April 1, 2013

Enrollment Period

2.3 years

First QC Date

July 16, 2007

Last Update Submit

April 27, 2013

Conditions

ST-Elevation Myocardial Infarction

Keywords

InfarctionEndothelinPerfusion

Outcome Measures

Primary Outcomes (1)

  • Myocardial perfusion determined by CMR

    3 days

Secondary Outcomes (10)

  • Final infarct size determined by CMR

    3 days

  • Left ventricular function determined by CMR

    3 days/ 6 months (6-months Remodeling-substudy)

  • Plasma NT-BNP

    30 days/ 6 months (6-months substudy)

  • Enzymatic infarct size (CK levels)

    3 days

  • ECG ST-segment resolution

    1 hour

  • +5 more secondary outcomes

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo

Drug: Placebo

2

ACTIVE COMPARATOR

BQ-123

Drug: BQ-123

Interventions

PlaceboDRUG

Peri-interventional

Also known as: sodium salt
1
BQ-123DRUG

Peri-interventional

Also known as: Cyclo(-D-Trp-D-Asp-Pro-D-Val-Leu) sodium salt
2

Eligibility Criteria

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

You may qualify if:

  • STEMI patients (defined as: Evidence of ischemic chest pain for \>30 minutes within \<12 hours and new ST-segment elevation for ≥2 mm in two or more contiguous electrocardiographic leads or in case of a true posterior infarction reciprocal ST-segment depressions in in V1 and V2 \>1mm and/or elevated serum creatine phosphokinase or twofold elevation of troponin-T), aged 18 years and above, who undergo primary percutaneous revascularization (PCI) and have confirmed initial TIMI 0 or 1 in the infarct related coronary artery.

You may not qualify if:

  • Significant liver disease
  • Thrombolytic therapy
  • History of prior myocardial infarction
  • Current atrial fibrillation
  • History of congestive heart failure
  • History of migraine headache
  • Significant valvular heart disease, primary myocardial disease
  • Cardiogenic shock (sRR \<90mmHg or need for inotropic support)
  • Child-bearing potential
  • Inability to read, understand and sign the informed consent
  • Life expectancy \<3y
  • Prior organ transplantation
  • Medication with konazoles, ritonavir, rifampicin and sulfonyl-urea derivatives
  • Participation in another clinical study
  • Metal implants contraindicating CMR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Vienna-Austria, 1090, Austria

Location

Related Publications (1)

  • Adlbrecht C, Andreas M, Redwan B, Distelmaier K, Mascherbauer J, Kaider A, Wolzt M, Tilea IA, Neunteufl T, Delle-Karth G, Maurer G, Lang IM. Systemic endothelin receptor blockade in ST-segment elevation acute coronary syndrome protects the microvasculature: a randomised pilot study. EuroIntervention. 2012 Apr;7(12):1386-95. doi: 10.4244/EIJV7I12A218.

    PMID: 22522549RESULT

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionInfarction

Interventions

cyclo(Trp-Asp-Pro-Val-Leu)

Condition Hierarchy (Ancestors)

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

Study Officials

  • Irene M Lang, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

July 16, 2007

First Posted

July 17, 2007

Study Start

May 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2012

Last Updated

April 30, 2013

Record last verified: 2013-04

Locations

AU(1)