NCT00806403

Brief 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 mandated coronary angiography 5 to 7 days after inclusion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2001

Typical duration for phase_4

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 10, 2008

Completed
Same day until next milestone

Results Posted

Study results publicly available

December 10, 2008

Completed
Last Updated

December 10, 2008

Status Verified

November 1, 2008

Enrollment Period

1.6 years

First QC Date

November 7, 2008

Results QC Date

November 7, 2008

Last Update Submit

December 2, 2008

Conditions

Acute Myocardial Infarction

Keywords

thrombolysisprimary PCIabciximabST-segment resolutionTIMI flow

Outcome Measures

Primary Outcomes (2)

  • 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

    120 minutes after inclusion

  • 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.

    5-7 days after inclusion

Secondary Outcomes (3)

  • Death

    30 days

  • Reinfarction

    30 days

  • Stroke

    30 days

Study Arms (2)

thrombolysis

ACTIVE COMPARATOR
Drug: reteplase 10+10 U

invasive

ACTIVE COMPARATOR
Procedure: primary PCI

Interventions

reteplase 10+10 UDRUG

comparison to primary PCI

Also known as: Rapilysin
thrombolysis
primary PCIPROCEDURE

comparison to thrombolysis

Also known as: primary percutaneous coronary intervention
invasive

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Orebro University Hospital

Örebro, Sweden

Location

Sodersjukhuset

Stockholm, Sweden

Location

Norra Alvsborgs lans Hospital

Trollhättan, Sweden

Location

Varberg Hospital

Varberg, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 16569536RESULT

  • 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.

    PMID: 17925603RESULT

  • 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.

    PMID: 20691839DERIVED

MeSH Terms

Interventions

reteplase

Results Point of Contact

Title
Lars Grip
Organization
Sahlgren's University Hospital/S, Gothenburg
lars.grip@vgregion.se

Study Officials

  • Lars Grip, M.D. PhD

    Sahlgren's University Hospital/S

    PRINCIPAL INVESTIGATOR

  • Leif Svensson, M.D. PhD

    Stockholm South General Hospital

    STUDY CHAIR

  • Johan Herlitz, M.D. PhD

    Sahlgren's University Hospital/S

    STUDY CHAIR

  • Mikael Dellborg, M.D. PhD

    Sahlgren's University Hospital/O

    STUDY CHAIR

  • Ake Ohlsson, M.D. PhD

    Stockholm South General Hospital

    STUDY CHAIR

  • Mikael Aasa, M.D.

    Stockholm South General Hospital

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 7, 2008

First Posted

December 10, 2008

Study Start

November 1, 2001

Primary Completion

June 1, 2003

Study Completion

June 1, 2004

Last Updated

December 10, 2008

Results First Posted

December 10, 2008

Record last verified: 2008-11

Locations

SE(5)