This trial is active, not recruiting.

Condition st segment elevation myocardial infarction
Treatments conventional primary pci, ischemic postconditioning., deferred stenting in primary pci.
Sponsor Rigshospitalet, Denmark
Start date April 2011
End date February 2016
Trial size 2000 participants
Trial identifier NCT01435408, DANAMI-3


This study focuses on Cardioprotective strategies.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
(Active Comparator)
Conventional primary PCI in STEMI.
conventional primary pci pPCI
Conventional primary PCI in STEMI with implantation of DES.
Ischemic postconditioning in STEMI.
ischemic postconditioning. Ischemic postconditioning
Primary PCI in STEMI with implantation of DES. Following re-opening of the culprit artery mechanical postconditioning with 4 cycles of 30/30 sec. reperfusion/re-occlusion i performed.
Deferred strategy in STEMI.
deferred stenting in primary pci. Deferred stenting
In STEMI re-opening of the artery with guidewire/thrombectomy/small size balloon inflation DES stenting is postponed for 48 hours.

Primary Outcomes

All cause mortality, heart failure (postconditioning)
time frame: 2 years

Secondary Outcomes

Infarct size in relation to area at risk as determined by MRI after 3 month
time frame: 3 month
All cause mortality, myocardial infarction, repeat revascularisation and occurrence of definite stent thrombosis according to ARC definition within 1 year (deferred stent strategy)
time frame: 1 year

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Age ≥ 18 years. - Acute onset of chest pain of < 12 hours' duration. - ST-segment elevation ≥ 0.1 mV in ≥ 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block. Culprit lesion in a major native vessel. Exclusion Criteria: - Pregnancy. - Known intolerance of ASA, clopidogrel, heparin or contrast. - Inability to understand information or to provide informed consent. - Haemorrhagic diathesis or known coagulopathy. - Stent thrombosis.

Additional Information

Official title A Randomised Comparison of the Clinical Outcome After Postconditioning or Deferred Stent Implantation Versus Conventional Treatment
Principal investigator Lars Koeber, Prof., DMSci
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Rigshospitalet, Denmark.