| CTRI Number |
CTRI/2008/091/000191 [Registered on: 11/09/2009] |
| Last Modified On: |
06/12/2018 |
| Post Graduate Thesis |
|
| Type of Trial |
|
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
Pilot Study Targeting Normal Glucose in Patients with Acute Myocardial Infarction through appropriate use of insulin therapy.
|
Scientific Title of Study
Modification(s)
|
REsearching Coronary REduction by Appropriately Targeting Euglycemia ( Pilot Study):
An International Multicentre Randomized Controlled Trial of Intensive Insulin Therapy Targeting Normoglycemia In Acute Myocardial Infarction: the RECREATE (REsearching Coronary REduction by Appropriately Targeting Euglycemia) Pilot Study |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NCT00640991 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Denis Xavier |
| Designation |
|
| Affiliation |
|
| Address |
Division of Clinical Research and Training
St. Johns Research Institute, Koramangala
Bangalore
KARNATAKA
560034
India |
| Phone |
08049466140 |
| Fax |
08049467090 |
| Email |
drdenisxavier@hotmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Denis Xavier |
| Designation |
|
| Affiliation |
Principal Investigator |
| Address |
Division of Clinical Research and Training
Koramangala
Bangalore
KARNATAKA
560 034
India |
| Phone |
08049466140 |
| Fax |
08049467090 |
| Email |
denis.xavier@stjohns.in |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Denis Xavier |
| Designation |
|
| Affiliation |
|
| Address |
Division of Clinical Research and Training
Koramangala
Bangalore
KARNATAKA
560 034
India |
| Phone |
08049466140 |
| Fax |
08049467090 |
| Email |
denis.xavier@stjohns.in |
|
Source of Monetary or Material Support
Modification(s)
|
| Population Health Research Institute |
|
|
Primary Sponsor
|
| Name |
Aventis Pharma |
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Population Health Research Institute |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 17 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. B.N. Mahanta |
Assam MEdocal College & Hospital |
P/O Assam Medical College,Dt Dibrugarh-786002
|
03732300020
03732300080
drbnmahanta@hotmail.com |
| Dr. Archana Jain |
Avanti Institute of Cardiology Pvt.Ltd |
5, Abhyankar Road,Dhantoli-440012
Nagpur
MAHARASHTRA |
0712-2422408,2452509,09823143329
0712-2461599
drjain_avanti@yahoo.com |
| Dr. Ashokan Nambiar |
Baby Memorial Hospital |
Indira Gandhi Road,-673004
|
0495-2723272,09847001142
0495-2723484
info@babymhospital.org |
| Dr. B.K.S. Sastry |
Care Hospital |
Exhibition Ground,Nampally-500001
Hyderabad
ANDHRA PRADESH |
04030417327
04024608525
bkssastry@hotmail.com |
| Dr. Johny Joseph |
Caritas Hospital |
Thellakom (P.O),-686016
Kottayam
KERALA |
0481-2790025, 09447124948
1481- 2790163
caritascardio@gmail.com |
| Dr CB Patil |
Department of Cardiology, St. Johns Medical College & Hospital |
Koramangala,-560034
Bangalore
KARNATAKA |
cardioresearch@gmail.com |
| Dr. Nirmit V Yajnik |
Dr. B.R. Patel Hospital |
Opp. Brahmansabha Hall, Pratap Road,Dandia Bazar-390001
Vadodara
GUJARAT |
02652426112
02652436543
dr_nvyajnik@yahoo.com |
| Dr. Jitendra Singh |
Fortis Escorts Hospital |
JLN Marg,Malviya Nagar-302017
Jaipur
RAJASTHAN |
0141-2547000
0141-4008151
research_fortis@hotmail.com |
| Dr.Prafulla Gopinath Kerkar |
KEM Hospital & Seth G.S Medical College |
CVTC Building, 4th Floor,Acharya Donde Marg, Parel-400012
Mumbai
MAHARASHTRA |
022-24136051 ext- 2006, 09820144111
022- 24116732
prafullakerkar@rediffmail.com |
| Dr. Rajendra Kumar Premchand |
Krishna Institute of Medical Sciences Ltd |
Minister Raod,-500003
|
04027725363
04027845555
kumarpre@hotmail.com |
| Dr. Jawahar Agrawal M.D |
Life Worth Super Speciality Hospital |
Main Road,Samata Colony-492001
Raipur
CHHATTISGARH |
0771-4065400,09425204258
0771-4065444
lifeworthhospital@yahoo.co.in |
| S.P.Kalantri |
Mahatma Gandhi Institute of Medical Sciences |
Sevagram,-442102
Wardha
MAHARASHTRA |
07152-284967, 09970168766
07152-284967
spkalantri@gmail.com |
| Dr J Narendra |
Nanjappa Hospital |
,-
Shimoga
KARNATAKA |
nanjappa1987@dataone.in |
| Dr. P. Ramasamy |
P.S.G Hospital |
peelamedu,-641004
Coimbatore
TAMIL NADU |
04222570170
04222594400
drbhucbect@yahoo.co.in |
| Dr. V.K.Katyal |
Post Graduate Institute of Medical Sciences |
20/8 FM,Medical Enclave-124001
Rohtak
HARYANA |
09991258540
katyalvirender@hotmail.com |
| Dr. Manjusha Yadav |
Shreenath Hospital |
Anandvan Complex, Gorwa Road,Subhanpura-390023
|
02652395055
02652389694
yadav.manjusha@gmail.com |
| Dr. Kalanidhi |
Southern Railway HQ Hospital |
Ayanavaram,-600023
Chennai
TAMIL NADU |
044-26461008
044-26740426
drkalanidhi@gmail.com, dr_kalanidhi@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| BMH |
Approved |
| Ethics Committee for Research on Human Subjects, Seth G.S. Medical College & K.E.M. Hospital, Mumbai |
Approved |
| Ethics Committee, Avanti Institute of Cardiology Pvt. Ltd, Nagpur |
Approved |
| Ethics Committee, Baby Memorial Hospital, Calicut |
Approved |
| Ethics Committee, Caritus Hospital, Kottayam |
Approved |
| IEC Consultants |
Approved |
| IEC for research on Human Subjects, Mahatma Gandhi Institute of Medical Sciences, Wardha |
Approved |
| IERB |
Approved |
| Instiutional Human Ethics Committe, P.S.G. Hospital, Coimbatore |
Submittted/Under Review |
| Intitutional Ethical Committee, Assam Medical College, Dibrugarh |
Approved |
| Intitutional Ethical Committee, CARE Hospital, Hyderabad |
Submittted/Under Review |
| Intitutional Ethical Review Board, St. John's Medical Collehe & Hospital |
Approved |
| KIMS Institutional Ethics Committee, Secunderabad |
Submittted/Under Review |
| Office of the Institutional Ethics Committee, Fortis Escorts Hospital, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E086||Diabetes mellitus due to underlying condition with other specified complications, Hyperglycemia
Cardiovascular Diseases
Myocardial Infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drug: glulisine insulin, glargine insulin |
Acute phase, Intravenous Infusion
Continuos Phase, Insulin pen self administered |
| Comparator Agent |
No Intervention |
Standard Care |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
Both nondiabetic patients and patients with non-insulin-requiring type 2 diabetes mellitus admitted with a suspected AMI are eligible if they meet the following criteria:
Signs or symptoms of AMI with definite ECG changes, defined as persistent ST-segment elevation (> or = than 1 mm)in two or more contiguous leads, or new left bundle branch block
Onset of symptoms within 24 hours before hospital presentation
Capillary blood glucose level on presentation > or = 8.0 mmol/L (144 mg/dL)
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
Patient with conditions that REQUIRE the administration of insulin, including:
Type 1 diabetes mellitus, defined by a documented history of diabetes mellitus before the age of 30
Type 2 diabetes mellitus that was treated with insulin prior to AMI presentation
Type 2 diabetes mellitus that is known to be very poorly controlled (e.g. admission capillary blood glucose > 16.0 mmol/L (288 mg/dL)or marked elevation in glucose for which the site investigator plans to treat with insulin therapy)
A history of severe hypoglycemic episodes (defined as hypoglycemia with symptoms which the patient is unable to reverse without the assistance of another person) within the past two years
Known or suspected end-stage liver disease (due to the risk of hypoglycemia in the setting of liver dysfunction and consequent impaired regulation of glucose homeostasis)
Cardiogenic shock on admission (due to the inaccuracy of glucose meter readings)
Documented pregnancy
Any concomitant disease (e.g. cancer) that might limit life expectancy to less than 90 days
Anticipated poor adherence with study treatments or an other factor that might jeopardize 90-day follow-up (e.g. no fixed address, long distance to hospital, etc.)
Prior enrollment in this trial or current enrollment in another trial of ST-segment elevation myocardial infarction
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The 24-hour difference in mean glucose between the two study groups |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the difference in mean glucose level achieved between study groups;
|
7 days or hospital discharge (whichever is first) |
| b) the difference in mean glucose level between study groups;
|
achieved at 30 days |
| c) nonfatal recurrent myocardial infarction, nonfatal stroke, or cardiovascular death (as a
composite and as separate outcomes);
|
30 days |
| d) rehospitalization for congestive heart failure;
|
30 days |
| e) all cause mortality;
|
30 days |
| f) resuscitated cardiac arrest or life-threatening arrhythmia (as a composite and as separate outcomes);
|
30days |
| g) cardiogenic shock;
|
30days |
| h) cardiac procedures;
|
30 days |
| i) rehospitalization for any cause. |
30days |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/04/2008 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
|
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This pilot study will be a multicentre, randomized, open-label, controlled trial. The trial will be conducted in Canada, Argentina and India.
At least 500 patients presenting with AMI with ST-segment elevation or new left bundle branch block (LBBB), and a capillary blood glucose level on presentation ≥ 8.0 mmol/L (144 mg/dL), will be randomized in a 1:1 fashion via a 24-hour central system to receive either intensive insulin therapy with the goal of achieving and maintaining normoglycemia (intervention arm) or routine
AMI care (control arm) (Figure 1). India will recruit about 250 patients from 10 - 15 centres. The recruitment in India is expected to start in February 2009 and the last date of enrollment is 30th November 2009.
A cutoff of 8 mmol/l (144 mg/dL) has been selected because the subgroup of patients in CREATE-ECLA with a baseline glucose ≥ 8.0 mmol/L had a higher mortality rate at 30 days (12.7%) compared with patients with presenting glucose < 8.0 mmol/L (who had a 30-day mortality rate of 7.3%), and because insulin therapy is likely to be more efficacious in patients who present with higher glucose level |