Verification of the Safety of Early Discharge in Patients After Acute ST-segment Myocardial Infarction

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Municipal Hospital Ostrava
Sponsor:
Information provided by (Responsible Party):
Kamil Novobílský, Municipal Hospital Ostrava
ClinicalTrials.gov Identifier:
NCT02023983
First received: December 16, 2013
Last updated: April 28, 2014
Last verified: April 2014

December 16, 2013
April 28, 2014
November 2013
February 2017   (final data collection date for primary outcome measure)
• Composite of incidence of death, reinfarction, unstable angina pectoris, stroke, unplanned rehospitalization, repeat target vessel revascularization and stent thrombosis in 30 days after myocardial infarction (MI) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT02023983 on ClinicalTrials.gov Archive Site
  • Composite of incidence of death, reinfarction, unstable angina pectoris, stroke, unplanned rehospitalization, repeat target vessel revascularization and stent thrombosis in 90 days after MI [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Complications associated with the puncture site requiring treatment in 30 days after myocardial infarction (MI) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Composite of incidence of death, reinfarction, unstable angina pectoris, stroke, unplanned rehospitalization, repeat target vessel revascularization and stent thrombosis in 90 days after MI [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Bleeding complications associated with the puncture site in 30 days after myocardial infarction (MI) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Verification of the Safety of Early Discharge in Patients After Acute ST-segment Myocardial Infarction
Official Title Verification of the Safety of Early Discharge (Within 72 Hours) in Low Risk Patients After Acute ST-segment Elevation Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention. Open Randomized Study.

The aim of the study is to prove that early discharge (within 72 hours) in selected group of patients after myocardial infarction with elevations of ST-segment is feasible and safe

The aim of the study is to prove

  • that early discharge (within 72 hours) in selected group of patients with low risk of follow-up complications after myocardial infarction with elevations of ST-segment, treated with primary percutaneous coronary intervention, is feasible and safe
  • that early discharge is "non-inferior" in comparison with the group of patients, discharged in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day), thus it is not associated with higher incidence of complications in 30th and 90th day after myocardial infarction
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Coronary Artery Disease
  • Acute Myocardial Infarction With ST-segment Elevation
  • Primary Percutaneous Coronary Intervention
  • Early Discharge
  • Other: Early discharge
    Early discharge (within 72 hours) of selected patients with low risk of complications after myocardial infarction with ST segment elevation, treated with successful percutaneous coronary intervention
  • Other: Standard discharge
    Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)
  • Experimental: Early discharge
    Intervention: Other: Early discharge
  • Active Comparator: Standard discharge
    Intervention: Other: Standard discharge
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
May 2017
February 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Signed informed consent
  • Age ≥18 do ≤ 75 years
  • Acute myocardial infarction with ST-segment elevation, treated with successful percutaneous coronary intervention within 12 hours from the onset of symptoms
  • Left ventricle ejection fraction ≥ 45% by echocardiography
  • Single- or two-vessel disease (stenosis of major epicardial artery ≥ 70%)
  • Haemodynamic and rhythmic stability (Killip class I, no arrythmia requiring treatment occurring > 2 hours after PCI)
  • Assumed good cooperation and social background

Exclusion Criteria:

  • Symptoms of residual ischemia
  • Significant comorbidities or abnormalities in paraclinical tests, requiring additional evaluation within continuing hospitalization
  • Contraindication of dual antiplatelet therapy or need for anticoagulation therapy
  • Hihg risk of bleeding complications
  • Participation in other clinical study
Both
18 Years to 75 Years
No
Czech Republic
 
NCT02023983
KN-11-2013
No
Kamil Novobílský, Municipal Hospital Ostrava
Kamil Novobílský
Not Provided
Not Provided
Municipal Hospital Ostrava
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP