| CTRI Number |
CTRI/2009/091/000052 [Registered on: 17/07/2009] |
| Last Modified On: |
09/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Follow Up Study |
| Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial. |
Scientific Title of Study
Modification(s)
|
An International Randomised Controlled Trial to Establish the Effects of Early Intensive Blood Pressure Lowering in Patients With Intracerebral Haemorrhage |
| Trial Acronym |
INTERACT2 |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| ACTRN12608000362392 |
ANZCTR |
| ISRCTN73916115 |
ISRCTN |
| NCT00716079 |
ClinicalTrials.gov |
| NHMRC-571281:2 |
Other |
| Protocol version 1.1 dated 21 July 2008 |
Other |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Jeyaraj D Pandian |
| Designation |
National coordinator |
| Affiliation |
|
| Address |
Dept of Neurology, Head of Research, Betty Cowan Research and Innovation center, Christian medical College.
Ludhiana
PUNJAB
141008
India |
| Phone |
0161-2220850 |
| Fax |
0161-2220850 |
| Email |
jeyarajpandian@hotmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Jeyaraj D Pandian |
| Designation |
National Coordinator |
| Affiliation |
National Coordinator |
| Address |
Department of Neurology, Head of Research, Betty Cowan Research and Innovation Center, Christian Medical College and Hospital
Ludhiana
PUNJAB
141008
India |
| Phone |
0161-222-850 |
| Fax |
0161-2220850 |
| Email |
jeyarajpandian@hotmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
KMallikarjuna |
| Designation |
Clinical research associate |
| Affiliation |
|
| Address |
839C,Road no 44A, Jubilee Hills
Hyderabad
ANDHRA PRADESH
500033
India |
| Phone |
040-23558091 |
| Fax |
040-23541980 |
| Email |
k.mallikarjuna@georgeclinical.com |
|
Source of Monetary or Material Support
Modification(s)
|
| The National Health and medical research Council (NHMRC) of Australia |
|
Primary Sponsor
Modification(s)
|
| Name |
The National Health and Medical Research Council NHMRC of Australia |
| Address |
Level 1
16 Marcus Clarke Street
GPO Box 1421
Canberra ACT 2601 |
| Type of Sponsor |
Government funding agency |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India
Argentina
Australia
Belgium
Brazil
Chile
Finland
Germany
Hong Kong
Italy
Netherlands
Norway
Pakistan
Portugal
Spain
Switzerland
United Kingdom
United States of America
Austria
China
France |
Sites of Study
Modification(s)
|
| No of Sites = 13 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Dedeepiya Devaprasad |
Apollo Hospital |
Greams lane, Off Greams Road,-600006
Chennai
TAMIL NADU |
9444216333
dedeepiya_76@yahoo.co.in |
| Dr. Subhashini Prabhakar |
Apollo Hospitals, Hyderabad |
Dept. of Neurology, Apollo Hospitals, Jubilee Hills, Hyderabad- 500033, A.P, India,,-500033
Hyderabad
ANDHRA PRADESH |
subhashiniprabakar@yahoo.co.in |
| Dr. K A Salam |
Baby Memorial Hospital |
I. G. Road,-673004
|
495-2723272
495-2723484
salamnaha@rediffmail.com |
| Dr. J M K Murthy |
CARE Hospital |
Nampally,-500001
Hyderabad
ANDHRA PRADESH |
9701700090
jmkmurthy@satyam.net.in |
| Dr. J D Pandain |
Christian Medical College, Ludhiyana |
Dept. of Neurology, Betty Cowan Research and Innovation Center,-
|
jayarajpandian@hotmail.com |
| Dr. M M Mehendiratta |
G B Pant, Delhi |
Dept. of Neurlogy, Suite 502, Academic Block, G. B. Pant Hospital, ,-110002
New Delhi
DELHI |
mmmresearch@gmail.com |
| Dr. Nomal Chandra Borah |
GNRC |
Dispur,-781006
|
0361-2227717
0361-2227711
ncborah@usa.net |
| Dr. N. R. Ichaporia |
Jahangir Hospital, Pune |
Jehangir Clinical Development Center Pvt. Ltd., Jehangir Hospital Premises, 32, Sasoon Road,-411001
Pune
MAHARASHTRA |
|
| Dr. P. Vijaya |
Lalitha Super Speciality Hospital |
Kothapet, ,-522001
Guntur
ANDHRA PRADESH |
91 9440808621
vijayapvr@yahoo.com |
| Dr. Dheeraj Khurana |
PGI Chandigarh |
Dept. of Neurology, Postgraduate Institute of Medical Education and Research,-160012
Chandigarh
CHANDIGARH |
|
| Dr. Mustaq Ahmed Wani |
Sher I Kashmir |
Srinagar,-1900011
Srinagar
JAMMU & KASHMIR |
9419000275
mushtaq_wani@hotmail.com |
| Dr. G R K Sarma |
St. John's Medical College & Hospital |
John Nagar,-560034
Bangalore
KARNATAKA |
080-22065330
080-25634479
grk_sarma@yahoo.com |
| Dr. Vikram Sharma |
St. Theresa's Hospital |
Erragadda, Sanathnagar,-500016
Hyderabad
ANDHRA PRADESH |
040-23704411,ext-359
drvikramsharma@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| Ethics committe Apollo Hospitals, Hyderabad |
Approved |
| Ethics Committe Christian Medical Colloege and Hospital, Ludhiana |
Approved |
| Ethics Committee of Nizam?s Institute of Medical Sciences, NIMS Hospital, Hyderabad |
Approved |
| Ethics Committee-Apollo Hospitals, Chennai |
Approved |
| Hirabai Cowasji Jehangir Medical Research Institute & Jehangir Clinical Development Centre Ethics Committee, Jehangir Hospital, Pune |
Approved |
| Institute Ethics Committee, PGIMER, Chandigarh |
Approved |
| Institute of Ethics Committee, Sher-i-kashmir Institute of Medical Sciences, Sher i Kashmir Institute of Medical Sciences, Srinagar |
Approved |
| Institute of Neurological Science Ethics Committee, GNRC, Guwahati |
Approved |
| Institutional Ethical Committee, CARE Foundation, CARE Hospital,Banjara Hills, Hyderabad |
Approved |
| Institutional Ethical Review Board, St. Johns Medical College Hospital, Bangalore |
Approved |
| Institutional Ethics Committee MAMC & Associated Hospitals, G B Pant Hospital, Delhi |
Approved |
| Lalitha Super Specaility Hospital Ethics Committe, Kothapet,Guntur-52001 |
Approved |
| St Theresas Ethics Committee,ST.Theresas Hospital,Erragadda,Sanathnagar Hyderabad |
Approved |
| The institutional Ethics committee, Baby Memoral Hospital,Kerela |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Intracerebral Haemorrhage Stroke
Hypertension , (1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Conservative Management of Blood Pressure |
Conservative arm: Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved. Drugs : Labetalol Hydrochloride Metoprolol tartrate Hydralazine Hydrochloride Glycerol Trinitrate Phentolamine mesylate Nicardipine Urapidil Esmolol Clonidine Enalaprilat Nitroprusside
[ |
| Intervention |
Intensive Blood pressure reduction |
Intensive arm: Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient older than 18 years old (there is no upper age limit).
2.Acute stroke syndrome due to spontaneous ICH, confirmed by clinical history and CT scan
3.At least two systolic BP measurements of more than or equal to 150 mmHg and less than or equal to 220 mmHg, recorded 2 or more minutes apart.
4.Able to commence randomly assigned BP lowering regimen within 6 hours of stroke onset.
5.Able to be ‘actively’ treated and admitted to a monitored facility |
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1.Clear indication or contraindication to intensive BP lowering.
2.Evidence ICH secondary to a structural abnormality
3.Recent (within 1 month) use of a thrombolytic agent
4.Previous ischaemic stroke within 30 days
5.A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria
6.Score of 3-5 on the Glasgow Coma Scale (indicating deep coma)
7.Significant pre-stroke disability or advanced dementia
8.Planned early neurological intervention
9.Participation in another clinical trial.
10.A high likelihood that the patient will not adhere to the study treatment and follow-up regimen.
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Measure: A composite of death or dependency, with dependency being defined by a score of 3 to 5 on the modified Rankin Scale (mRS)
|
Time Frame: 90 days
|
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
To assess the effect of the treatment on the primary outcome in a subgroup of patients who receive treatment within 4 hours of ICH onset.
Other secondary outcomes
1.Mortality, Dependency(measured by mRS)& HRQoL (measured by the EuroQuol5D) at Day 28&90
4.Recurrent stroke
5.Acute myocardial infarction (or sudden death) from a cardiovascular cause
6.Need for permanent residential care
7.Duration of initial hospital stay |
1.Mortality at 28 days and 90 days
2.Dependency (measured by mRS) at 28 days and 90 days
3.HRQoL (measured by the EuroQuol 5D) at 28 days and 90 days.
4.Recurrent stroke after 24 hours of the initial ICH.
5.Acute myocardial infarction (or sudden death) from a cardiovascular cause, according to standard definitions.
6.Need for permanent residential care
7.Duration of initial hospital stay |
|
Target Sample Size
Modification(s)
|
Total Sample Size="2839"
Sample Size from India="97"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
11/08/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/10/2008 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1. Rev Neurol (Paris). 2011 Nov 28.
2. International Journal of Stroke Volume 5, Issue 2, pages 110–116, April 2010 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
600 patients wiil be recruited in India into the study. The recruitment has began in August 2010..Patients will be randomised to either intensive blood pressure lowering or current guideline based management. As the trial is an assessment of blood pressure (BP) management policies, there is some flexibility in the use of particular BP lowering agents to achieve BP targets. Intravenous treatment protocols, based on available medications, are provided. Only licensed drugs are used such as labetolol hydrochloride, metoprolol tartrate, hydralazine hydrochloride, glyceral trinitrate and phentolamine. Intensive therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140 mmHg within 1 hour and to maintain this pressure over the next 7 days of the patient's period of hospitalisation. Where possible, oral (or nasogastric) treatment should also be commenced within 24 hours. Control group therapy will include less intensive management of BP using similar choice of route and agents if systolic blood pressure rises above 180 mmHg. The blood pressure target for the control group according to guidelines is a systolic of 180 mmHg. In-person or telephone based follow-up of surviving patients is planned for 3 months in both groups.22 patients have been randomized till date in the study. |