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Acute Myocardial InfarctionPhase 4SWEDESNCT00806403

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

A Phase 4 study testing reteplase 10+10 U and primary PCI in people with Acute Myocardial Infarction, run by Sahlgrenska University Hospital at 5 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
reteplase 10+10 U and primary PCI
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
205 participants
Where
5 sitesSweden
Study dates
Nov 2001to Jun 2004
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Sweden5 sites

  • Sahlgrenska University Hospital

    Gothenburg

  • Orebro University Hospital

    Örebro

  • Sodersjukhuset

    Stockholm

  • Norra Alvsborgs lans Hospital

    Trollhättan

  • Varberg Hospital

    Varberg

Other trials in Sweden

About this study

Official 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

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.

Read the detailed description

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.

Being tested
reteplase 10+10 U, primary PCI
Keywords
thrombolysis, primary PCI, abciximab, ST-segment resolution, TIMI flow

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • reteplase 10+10 UDrug

    Also called Rapilysin

    comparison to primary PCI

  • primary PCIProcedure or surgery

    Also called primary percutaneous coronary intervention

    comparison to thrombolysis

Study groups in NCT00806403
Study groupRoleWhat they receive
thrombolysisActive comparatorNot described
Receives: Drug: reteplase 10+10 U
invasiveActive comparatorNot described
Receives: Procedure: primary PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 120 minutes after inclusion

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

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

    Measured: 5-7 days after inclusion

Secondary outcomes (3)

  1. Death

    Measured: 30 days

  2. Reinfarction

    Measured: 30 days

  3. Stroke

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2008 (estimated)
  2. Study startNov 2001
  3. Primary completionJun 2003
  4. Study completionJun 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
205 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00806403
Sponsor's protocol ID
SWEDES 23/09/01
Acronym
SWEDES
Status last verified
Nov 2008
First submitted
7 Nov 2008
Last updated
10 Dec 2008
Data monitoring committee
Yes

Publications

  • Svensson L, Aasa M, Dellborg M, Gibson CM, Kirtane A, Herlitz J, Ohlsson A, Karlsson T, Grip L. Comparison of very early treatment with either fibrinolysis or percutaneous coronary intervention facilitated with abciximab with respect to ST recovery and infarct-related artery epicardial flow in patients with acute ST-segment elevation myocardial infarction: the Swedish Early Decision (SWEDES) reperfusion trial. Am Heart J. 2006 Apr;151(4):798.e1-7. doi: 10.1016/j.ahj.2005.09.013.

    PubMed 16569536

  • Aasa M, Kirtane AJ, Dellborg M, Gibson MC, Prahl-Abrahamsson U, Svensson L, Grip L. Temporal changes in TIMI myocardial perfusion grade in relation to epicardial flow, ST-resolution and left ventricular function after primary percutaneous coronary intervention. Coron Artery Dis. 2007 Nov;18(7):513-8. doi: 10.1097/MCA.0b013e3282c1fdb6.

    PubMed 17925603

  • Aasa M, Henriksson M, Dellborg M, Grip L, Herlitz J, Levin LA, Svensson L, Janzon M. Cost and health outcome of primary percutaneous coronary intervention versus thrombolysis in acute ST-segment elevation myocardial infarction-Results of the Swedish Early Decision reperfusion Study (SWEDES) trial. Am Heart J. 2010 Aug;160(2):322-8. doi: 10.1016/j.ahj.2010.05.008.

    PubMed 20691839

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing reteplase 10+10 U and primary PCI in people with Acute Myocardial Infarction, run by Sahlgrenska University Hospital at 5 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Dec 2008). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With ST-segment Elevation Resolution Equal or More Than 50% (time frame: 120 minutes after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00806403, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2008.

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