Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Sponsor:
Collaborators:
Stockholm South General Hospital
Region Örebro County
Norra Alvsborgs Lans Hospital, Trollhattan
Varberg Hospital, Sweden
Information provided by:
Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT00806403
First received: November 7, 2008
Last updated: December 2, 2008
Last verified: November 2008
Results First Received: November 7, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acute Myocardial Infarction
Interventions: Drug: reteplase 10+10 U
Procedure: primary PCI

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From Nov. 2001 to May 2003. Cardiology Departments

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Thrombolysis Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
Invasive 500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.

Participant Flow:   Overall Study
    Thrombolysis   Invasive
STARTED   104   101 
COMPLETED   100   98 
NOT COMPLETED   4   3 
Death                4                3 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Thrombolysis Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
Invasive 500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
Total Total of all reporting groups

Baseline Measures
   Thrombolysis   Invasive   Total 
Overall Participants Analyzed 
[Units: Participants]
 104   101   205 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   55   49   104 
>=65 years   49   52   101 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.3  (12.4)   65.3  (10.9)   64.8  (11.7) 
Gender 
[Units: Participants]
     
Female   26   27   53 
Male   78   74   152 
Region of Enrollment 
[Units: Participants]
     
Sweden   104   101   205 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients With ST-segment Elevation Resolution Equal or More Than 50%   [ Time Frame: 120 minutes after inclusion ]

2.  Primary:   Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3   [ Time Frame: 5-7 days after inclusion ]

3.  Secondary:   Death   [ Time Frame: 30 days ]

4.  Secondary:   Reinfarction   [ Time Frame: 30 days ]

5.  Secondary:   Stroke   [ Time Frame: 30 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lars Grip
Organization: Sahlgren's University Hospital/S, Gothenburg
e-mail: lars.grip@vgregion.se


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Lars Grip, Sahlgrenska University Hospital
ClinicalTrials.gov Identifier: NCT00806403     History of Changes
Other Study ID Numbers: SWEDES 23/09/01
Study First Received: November 7, 2008
Results First Received: November 7, 2008
Last Updated: December 2, 2008