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Completed

NCT Number: NCT00806403

Comparison Between Thrombolysis and Primary Percutaneous Coronary Intervention (PCI) to Treat ST-Segment Elevation Myocardial Infarction

The main objective is to compare a fibrinolytic strategy with an interventional strategy initiated as early as possible, preferably in the pre-hospital phase, with respect to resolution of ST-segment elevation at 120 minutes after inclusion and Thrombolysis In Myocardial Infarction (TIMI) flow grade evaluated at a mandated coronary angiography 5 to 7 days after inclusion.

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Key information

Conditions

Acute Myocardial Infarction

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sahlgrenska University Hospital, Gothenburg, Sweden

Loading trial locations.

About this study

Patients in the fibrinolytic group received an intravenous injection of 30 mg enoxaparin followed by subcutaneous injections of 1 mg/kg body weight every 12 hours during hospital stay.

Patients in the invasive group were given an intravenous injection of enoxaparin of (0.75 mg/kg body weight) and abciximab as a intravenous bolus (0.25 mg/kg body weight) followed by a 12 hour infusion (10 microg/minute).

Secondary outcome measures were death, myocardial infarction and stroke alone or as a composite at 30 days.

Data on use of health care resources, loss of production and health-related quality of life were collected during one year. Cost-effectiveness was determined by comparing costs and quality-adjusted survival.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients presenting within 6 h after onset of chest pain lasting for more than 30 min and with significant ST-segment elevation on ECG.

Exclusion criteria

  • BP >180/110
  • Known bleeding disorder
  • Cardiogenic shock
  • CPR>10 min
  • Ongoing anticoagulant therapy
  • Renal insufficiency
  • Weight >120 kg

Treatment and study plan

reteplase 10+10 U

Drug

comparison to primary PCI

Other names: Rapilysin

Primary PCI

Procedure

comparison to thrombolysis

Other names: primary percutaneous coronary intervention

Primary outcomes

  1. Number of Patients With ST-segment Elevation Resolution Equal or More Than 50%

    Time frame: 120 minutes after inclusion

    ST-segment elevation resolution was measured in the lead with most prominent ST elevation at time of inclusion

  2. Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3

    Time frame: 5-7 days after inclusion

    Thrombolysis In Myocardial Infarction (TIMI) flow grade in the infarct related artery 5-7 days after inclusion.

Secondary outcomes

  1. Death

    Time frame: 30 days

  2. Reinfarction

    Time frame: 30 days

  3. Stroke

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Collaborators

  • Norra Alvsborgs Lans Hospital, Trollhattan
  • Region Örebro County
  • Stockholm South General Hospital
  • Varberg Hospital, Sweden

Registry information

Official study title

Very Early Initiation of Treatment With Thrombolysis and Low Molecular Weight Heparin, Versus Abciximab and Low Molecular Weight Heparin Followed by Percutaneous Coronary Intervention, for Acute ST-Elevation Myocardial Infarction

Acronym: SWEDES

Important dates

Study start
2001
Primary completion
2003
Study completion
2004
First posted
Dec 10, 2008
Registry last updated
Dec 10, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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