MedDataX Logo

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

NCT ID: NCT00806403

Last Updated: 2008-12-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2004-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Myocardial Infarction

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

thrombolysis primary PCI abciximab ST-segment resolution TIMI flow

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

thrombolysis

Group Type ACTIVE_COMPARATOR

reteplase 10+10 U

Intervention Type DRUG

comparison to primary PCI

invasive

Group Type ACTIVE_COMPARATOR

primary PCI

Intervention Type PROCEDURE

comparison to thrombolysis

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

reteplase 10+10 U

comparison to primary PCI

Intervention Type DRUG

primary PCI

comparison to thrombolysis

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Rapilysin primary percutaneous coronary intervention

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stockholm South General Hospital

OTHER

Sponsor Role collaborator

Region Örebro County

OTHER

Sponsor Role collaborator

Norra Alvsborgs Lans Hospital, Trollhattan

UNKNOWN

Sponsor Role collaborator

Varberg Hospital, Sweden

OTHER

Sponsor Role collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sahlgrenska University Hospital

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lars Grip, M.D. PhD

Role: PRINCIPAL_INVESTIGATOR

Sahlgren's University Hospital/S

Leif Svensson, M.D. PhD

Role: STUDY_CHAIR

Stockholm South General Hospital

Johan Herlitz, M.D. PhD

Role: STUDY_CHAIR

Sahlgren's University Hospital/S

Mikael Dellborg, M.D. PhD

Role: STUDY_CHAIR

Sahlgren's University Hospital/O

Ake Ohlsson, M.D. PhD

Role: STUDY_CHAIR

Stockholm South General Hospital

Mikael Aasa, M.D.

Role: STUDY_CHAIR

Stockholm South General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status

Orebro University Hospital

Örebro, , Sweden

Site Status

Sodersjukhuset

Stockholm, , Sweden

Site Status

Norra Alvsborgs lans Hospital

Trollhättan, , Sweden

Site Status

Varberg Hospital

Varberg, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 16569536 (View on PubMed)

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.

Reference Type RESULT
PMID: 17925603 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20691839 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SWEDES 23/09/01

Identifier Type: -

Identifier Source: org_study_id