Southwest German Interventional Study in Acute Myocardial Infarction III (SIAMIII)

University Hospital, Saarland

Status and phase: Completed; Phase 4

Conditions: Acute Myocardial Infarction

Treatments: Device: early percutaneous coronary intervention; Device: late percutaneous coronary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01124890

BS S3

Details and patient eligibility

About

SIAM III was a multicenter, randomized, prospective, controlled trial in patients with ST-elevation myocardial infarction receiving fibrinolysis <12 hours after onset of symptoms. Patients of the early PCI group were transferred within 6 hours after fibrinolysis for PCI. The conservative group received elective PCI two weeks after fibrinolysis.

Full description

SIAM III was a multicenter, randomized, prospective, controlled trial in patients with ST-elevation myocardial infarction receiving fibrinolysis <12 hours after onset of symptoms. All patients received reteplase, aspirin in combination with ticlopidin, and heparin. Patients of the early PCI group were transferred within 6 hours after fibrinolysis for PCI. The conservative group received elective PCI two weeks after fibrinolysis. In total 197 patients were included, 163 were treated by PCI. The primary end point was the composite of ischemic events, death, reinfarction, and target lesion revascularization.

Enrollment: 197 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptoms of MI present for 12 h
• ST segment elevation of at least 1 mm in two or more limb leads,
• ST segment elevation of at least 2 mm in the precordial leads,
• or new bundlebranch block
• Patients eligible for thrombolysis
• Informed consent for participation

Exclusion criteria

• Secondary or iatrogenic infarction
• Chronic renal insufficiency requiring dialysis
• Coronary anatomy unsuitable for stent placement
• Anticipated indication for surgical coronary revascularization within 6 months
• Previous MI in the area of the infarct related vessel
• Infarct related lesion not clearly defined

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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197 participants in 2 patient groups, including a placebo group

Conservative

Placebo Comparator group

Description:

no transfer for early percutaneous coronary intervention after thrombolysis

Treatment:

Device: late percutaneous coronary intervention

early PCI

Active Comparator group

Description:

transfer for early percutaneous coronary intervention after thrombolysis

Treatment:

Device: early percutaneous coronary intervention