|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT00965406 |
|
Date of registration:
|
24/08/2009 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Glucose Insulin Potassium With Intensive Insulin Therapy and (GIK2) Versus GIK Alone
|
|
Scientific title:
|
Glucose Insulin Potassium With Intensive Insulin Therapy and (GIK2) Versus GIK Alone in the Early Management of Acute Coronary Syndrome: Randomised Controlled Study |
|
Date of first enrolment:
|
August 2010 |
|
Target sample size:
|
772 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00965406 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Tunisia
| | | | | | | |
|
Contacts
|
|
Name:
|
nouira semir, Prof. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Research Laboratory (LR12SP18) University of Monastir Tunisia |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- All patients fulfilling ACS criteria with or without known diabetes.
Exclusion Criteria:
- Patients under 18 years old.
- Killip II class or SaO2 = 90%.
- Blood creatinine = 180 µmol/L
- Potassium serum = 6.5 mmol/L.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Acute Coronary Syndrome
|
|
Intervention(s)
|
|
Drug: GIK and intensive insulin therapy
|
|
Primary Outcome(s)
|
|
30 days mortality, reinfarction, urgent coronary revascularisation, and stroke.
[Time Frame: 24 hours]
|
|
Secondary Outcome(s)
|
|
Severe dysrhythmias, acute left ventricular failure with ejection fraction<45%, serum troponin, PAI level and platelet factor activator (PFA-100) within 24 hours after the start of protocol treatment. Safety: major or minor hypoglycemia
[Time Frame: 24 hours]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|