StrokeSPRINTNCT03228979
Secondary Prevention By Structured Semi-Interactive Stroke Prevention Package in INDIA (SPRINT INDIA) Study
A study testing Structured Semi-Interactive Stroke Prevention Package in people with Stroke, run by Christian Medical College and Hospital, Ludhiana, India at 1 site in India.
Trial summary
Recurrent stroke, cardiovascular morbidity and mortality are important causes of poor outcome in patients with index stroke. According to the INTERSTROKE study, 80% of stroke are preventable due to the presence of modifiable risk factors. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stroke
- What is being tested?
- Structured Semi-Interactive Stroke Prevention Package
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,830 participants
- Where
- 1 siteIndia
- Study dates
- 28 Apr 2018to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and above including both men and women
- First-ever Ischemic stroke or intracerebral haemorrhage
- Between 2 days-3 months of stroke symptom onset
- Computed Tomography /Magnetic Resonance Imaging shows recent stroke (infarct and/or hemorrhage)
- Able to read and complete simple tasks suggested in the stroke workbook if having aphasia or is illiterate, a caregiver is available to read for the patients and complete the reading/workbook tasks for the patients.
- Able to read and possess a working personal mobile cellular device. In case of patients who is not able to read and/or don't have a personal mobile cellular device or unable to use it, a caregiver is available all times who is able to use mobile cellular devices and read to the patient.
Show all 9Show fewer
- Able to watch health education videos on a video player on cellular device or any other video player available to the patient.
- Able to come for follow up visits for at least 1 year
- Able to provide signed informed consent.
Who cannot join
- Modified Rankin scale score 0 and 1 at the time of enrollment
- Limited internet and/or mobile accessibility due to travel
- Patients having active malignancies needing intensive therapy
- Patients with a terminal illness with an anticipated lifespan of less than 1 year
- Patients with heart failure admitted more than twice in the last six months
- Patients with current psychiatric illness with loss of insight and suicide attempts
- Patients with cerebral venous sinus thrombosis, aneurysmal subarachnoid haemorrhage, isolated central nervous system vasculitis and systemic vasculitis
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Christian Medical College and Hospital
Ludhiana, Punjab, 141008
Jeyaraj D Pandian, MD DM, 9915784750, jeyarajpandian@hotmail.com
Jeyaraj D Pandian, MD DM FRACP
About this study
Recurrent stroke, cardiovascular morbidity and mortality are important causes of poor outcome in patients with index stroke. According to the INTERSTROKE study, 80% of stroke are preventable due to the presence of modifiable risk factors. However, the lack of knowledge that stroke and cardiovascular diseases are preventable is a major hurdle to reduce the incidence of recurrent stroke and cardiovascular morbidity. This is further compounded by the non-compliance to medications, exercises smoking cessation and other lifestyle modifications.
Stroke awareness has proven to be useful in improving the early arrival of stroke patients to emergency thus increasing the thrombolysis rates. Early stroke prevention education using print and audio-visual media may be useful. In addition, the use of pervasive mobile phone platform may help us reach patients during multiple intervals in a timely manner.
The study aims to use structured semi-interactive stroke prevention package to reduce the risk of recurrent strokes, myocardial infarction and death in patients with sub-acute stroke.
Read the detailed description
Stroke is the second leading cause of death worldwide in 2010. In rural Maharashtra, it is the leading cause of death. The Stroke incidence in India ranges from 135 to 145 per 100,000 population. From the recent Ludhiana population-based Stroke Registry and also from the INSPIRE Registry 25% of the patients are below 49 years of age. Hypertension, smoking, alcohol, diabetes, heart disease and lifestyle-related problems are the common causes of stroke in India. Rheumatic heart disease and cerebral venous thrombosis are the main etiologies of stroke in the young in our country.
Recurrent stroke
In an Oxfordshire Community Stroke Project reported in 1994, it was found that actuarial risk of suffering a recurrence was 30% (95% confidence interval, 20% to 39%) by 5 years, about nine times the risk of stroke in the general population. The risk was highest early after the first stroke: 13% (95% confidence interval, 10% to 16%) by 1 year, 15 times the risk in the general population. After the first year, the average annual risk was about 4%.
In the Copenhagen Stroke Study, stroke was recurrent in 23% despite most of these patients being given prophylactic treatment prior to recurrence. Only 12% of patients with atrial fibrillation were receiving anticoagulant treatment prior to recurrence. In multivariate analysis, recurrence was more frequently associated with a history of transient ischemic attack (TIA), atrial fibrillation, male gender, and hypertension, but not with age, daily alcohol consumption, smoking, diabetes, ischemic heart disease, serum cholesterol or hematocrit. Mortality was almost doubled compared with patients with a first-ever stroke. In survivors, however, both neurologic and functional outcomes and the speed of recovery were, in general, similar in the two groups. Despite similar neurologic impairments, patients with recurrence contralateral to their first stroke had markedly more severe functional disability after completed rehabilitation than patients with ipsilateral recurrence, implying that the ability to compensate functionally is decreased in patients with contralateral recurrence.
However, recently the rates of stroke recurrence have changed in developed countries. On average, the annual risk for future ischemic stroke after an initial ischemic stroke or TIA is ≈3% to 4%. Recent clinical trials of patients with non-cardio embolic ischemic stroke suggest the risk may be as low as 3%, but these data probably underestimate the community-based rate. The estimated risk for an individual patient will be affected by specific characteristics of the event and the person, including age, event type, comorbid illness, and adherence to preventive therapy. The current average annual rate of future stroke (≈3%-4%) represents a historical low that is the result of important discoveries in prevention science. These include antiplatelet therapy and effective strategies for the treatment of hypertension, atrial fibrillation, arterial obstruction and hyperlipidemia.
Even in developed nations currently, there are large gaps in the utilization of preventive drugs, control of risk factors, and uptake of lifestyle-changing behaviours. This is often because of failure in the initiation of secondary prevention.
Novel methods to improve the risk factor control to prevent recurrent stroke
In 2017, the number of mobile phone users is forecast to reach 4.77 billion. The number of mobile phone users in the world is expected to pass the five billion mark by 2019. In 2014, nearly 60 per cent of the population worldwide already owned a mobile phone. Mobile phone text messages can be used to remind, encourage, and motivate patients to adhere to secondary prevention strategies, but there has been limited robust scientific evaluation of these interventions.
Recurrent stroke in India
Data on recurrent stroke and its causes are scarce from low and middle-income countries like India. In the door-to-door survey done in Kolkata, 15% of patients had a recurrent stroke.
- Conditions
- Stroke
- Being tested
- Structured Semi-Interactive Stroke Prevention Package
- Keywords
- Secondary Prevention Package, Education
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Semi-Interactive Stroke Prevention PackageOther
The intervention arm will receive a Structured Semi-Interactive Stroke Prevention Package including patient workbook, short messaging services and health education videos for a period of one-year in addition to standard of care as per current guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Structured Semi-Interactive Prevention | Active comparator | The intervention arm will receive a Structured Semi-Interactive Stroke Prevention Package including patient workbook, short messaging services and health education videos for a period of one-year in addition to standard of care as per current guidelines Receives: Other: Structured Semi-Interactive Stroke Prevention Package |
| Control group | No intervention | Patients will receive standard post stroke care for 1 year |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular event
Primary outcome measure is a composite endpoint of Recurrent Stroke, high-risk Transient Ischemic Attack, Acute Coronary Syndrome and Death.
Measured: One year.
Secondary outcomes (11)
Systolic Blood Pressure (mmHg)
SBP is independent secondary outcome measure. Systolic Blood pressure will be assessed at baseline and one year. Limit 90-250. Lower score, better outcome.
Measured: One year.
Fasting Blood Glucose (mg/dl)
Fasting Blood Glucose will be assessed at baseline and one year. Limit 90-250. Lower score, better outcome. Limit 30-1000. Lower score, better outcome.
Measured: One year.
LDL Cholesterol (mg/dl)
LDL Cholesterol will be assessed at baseline and one year. Limit 30-1000. Lower score, better outcome.
Measured: One year.
Triglycerides (mg/dl)
Triglycerides will be assessed at baseline and one year. Limit 30-1500. Lower score, better outcome.
Measured: One year.
Smoking cessation (No/ total %)
Smoking cessation will be assessed at baseline and one year. Cessation of smoking at 1 year means better outcome.
Measured: One year.
Alcohol cessation
Alcohol cessation will be assessed at baseline and one year. Cessation of alcohol at 1 year means better outcome.
Measured: One year.
Body Mass Index (kg/m2)
Body Mass Index will be assessed at baseline and one year. Limit 15-50. Lower score, better outcome.
Measured: One year.
Physical Activity MET (min/week)
Physical Activity MET (Metabolic Equivalent of Task) will be assessed at baseline and one year. Limit 0-40000. Higher score better outcome.
Measured: One year.
Intervention Non-Compliance Assessment (INCA)
Intervention Non-Compliance Assessment (INCA) will be assessed at baseline and one year.
This measures is to note the adherence to the medication for the baseline to one year follow-up. The assessment is not score based. the question: "Have you missed your medication ever?", the more the patients mark NO will have the better outcome.
Measured: One year.
Modified Rankin Scale (mRS)
Modified Rankin Scale will be assessed at baseline and one year. Limit 0-5. Lower score, better outcome.
Measured: One year.
Diastolic Blood Pressure (mmHg)
Diastolic Blood pressure will be assessed at baseline and one year. Limit 60-140. A lower score, better outcome.
Measured: One year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start28 Apr 2018
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study is a multicenter, randomized, parallel-design, adaptive and blinded end-point clinical trial of sub-acute stroke patients
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5,830 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christian Medical College and Hospital, Ludhiana, India
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Council of Medical Research
- Responsible party
- Principal investigator, Jeyaraj D Pandian, Christian Medical College and Hospital, Ludhiana, India
- Investigators
- Jeyaraj D Pandian, MD DM, Principal investigator, Christian Medical College and Hospital, Ludhiana, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228979
- Sponsor's protocol ID
- SPRINT INDIA
- Acronym
- SPRINT
- Status last verified
- Jul 2021
- First submitted
- 3 Feb 2017
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All information collected from medical records for the study will be stored electronically in a specifically designed database at the Christian Medical College and Hospital, Ludhiana. Participants information will be identified only by their initials, date of birth and a study registration number. Any information transferred electronically will be coded to protect confidentiality. All computer records will be password protected. The study results may be presented at conferences or in scientific publications, but individual participants will not be identifiable. If needed, data will be available in future for other researchers outside the primary research group for secondary purposes, such as meta-analyses, reanalysis, or replication of results.
Publications
Chow CK, Redfern J, Thiagalingam A, Jan S, Whittaker R, Hackett M, Graves N, Mooney J, Hillis GS. Design and rationale of the tobacco, exercise and diet messages (TEXT ME) trial of a text message-based intervention for ongoing prevention of cardiovascular disease in people with coronary disease: a randomised controlled trial protocol. BMJ Open. 2012 Jan 19;2(1):e000606. doi: 10.1136/bmjopen-2011-000606. Print 2012.
PubMed 22267690Kamal AK, Shaikh Q, Pasha O, Azam I, Islam M, Memon AA, Rehman H, Akram MA, Affan M, Nazir S, Aziz S, Jan M, Andani A, Muqeet A, Ahmed B, Khoja S. A randomized controlled behavioral intervention trial to improve medication adherence in adult stroke patients with prescription tailored Short Messaging Service (SMS)-SMS4Stroke study. BMC Neurol. 2015 Oct 21;15:212. doi: 10.1186/s12883-015-0471-5.
PubMed 26486857Kumaravelu S, Verma SJ, Arora R, Arora D, Arya Devi KS, Dhasan A, Sylaja PN, Khurana D, Vijaya P, Ray B, Nambiar V, Aaron S, Mittal G, Nagarjunakonda S, Pai A, Reddy YM, Narayan S, Borah N, Das R, Kulkarni G, Huded V, Mathew T, Srivastava MVP, Bhatia R, Ojha P, Roy J, Abraham S, Vaishnav A, Sharma A, Jabeen SA, Pathak A, Bhoi S, Sharma S, Sulena S, Saroja AO, Ramrakhiani N, Kempegowda MB, Gorthi S, Kate M, George T, Sebastian I, Sharma M, Dhaliwal R, Huilgol R, Pandian JD. SPRINT INDIA: Regional Variations in Primary and Secondary Stroke Outcomes Based on Baseline Characteristics in North and South Indian Sites. Ann Indian Acad Neurol. 2025 May 1;28(3):378-386. doi: 10.4103/aian.aian_792_24. Epub 2025 May 7.
PubMed 40335450Verma SJ, Karuthedathu Mana Sanal Kumar AD, Arora D, Dhasan A, Sylaja PN, Khurana D, Vijaya P, Ray BK, Nambiar V, Aaron S, Mittal GK, Pai AR, Kumaravelu S, Reddy YM, Narayan S, Borah NC, Das R, Kulkarni GB, Huded V, Mathew T, Srivastava P, Bhatia R, Ojha PK, Roy J, Abraham SM, Vaishnav A, Sharma A, Pathak A, Bhoi SK, Sharma S, Sulena S, Saroja AO, Ramrakhiani N, Kempegowda MB, Gorthi SP, Kate MP, George T, Sebastian IA, Sharma M, Dhaliwal R, Huilgol R, Pandian JD. Comparing Stroke Profiles and Outcomes between Urban and Rural India: A Secondary Analysis of the SPRINT INDIA Trial. Cerebrovasc Dis. 2026;55(1):29-39. doi: 10.1159/000545675. Epub 2025 Apr 16.
PubMed 40239637SPRINT INDIA trial collaborators. Secondary prevention with a structured semi-interactive stroke prevention package in INDIA (SPRINT INDIA): a multicentre, randomised controlled trial. Lancet Glob Health. 2023 Mar;11(3):e425-e435. doi: 10.1016/S2214-109X(22)00544-7.
PubMed 36796986Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
PubMed 34813082Kate MP, Arora D, Verma SJ, Sylaja PN, Renjith V, Sharma M, Pandian JD; SPRINT India Collaborators. Secondary Prevention by Structured Semi-Interactive Stroke Prevention Package in India (SPRINT INDIA) study protocol. Int J Stroke. 2020 Jan;15(1):109-115. doi: 10.1177/1747493019895653. Epub 2019 Dec 18.
PubMed 31852411
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Prevention By Structured Semi-Interactive Stroke Prevention Package in INDIA (SPRINT INDIA) Study
- ClinicalTrials.gov ID
- NCT03228979
- Acronym / sponsor ID
- SPRINT / SPRINT INDIA
- Conditions
- Stroke
- Keywords
- Secondary Prevention Package, Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,830 participants (estimated)
- Lead sponsor
- Christian Medical College and Hospital, Ludhiana, IndiaUniversity, hospital or other
- Collaborators
- Indian Council of Medical Research
- Study start
- 28 Apr 2018 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 25 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recurrent stroke, cardiovascular morbidity and mortality are important causes of poor outcome in patients with index stroke. According to the INTERSTROKE study, 80% of stroke are preventable due to the presence of modifiable risk factors. However, the lack of knowledge that stroke and cardiovascular diseases are preventable is a major hurdle to reduce the incidence of recurrent stroke and cardiovascular morbidity. This is further compounded by the non-compliance to medications, exercises smoking cessation and other lifestyle modifications.
Stroke awareness has proven to be useful in improving the early arrival of stroke patients to emergency thus increasing the thrombolysis rates. Early stroke prevention education using print and audio-visual media may be useful. In addition, the use of pervasive mobile phone platform may help us reach patients during multiple intervals in a timely manner.
The study aims to use structured semi-interactive stroke prevention package to reduce the risk of recurrent strokes, myocardial infarction and death in patients with sub-acute stroke.
Detailed description
Stroke is the second leading cause of death worldwide in 2010. In rural Maharashtra, it is the leading cause of death. The Stroke incidence in India ranges from 135 to 145 per 100,000 population. From the recent Ludhiana population-based Stroke Registry and also from the INSPIRE Registry 25% of the patients are below 49 years of age. Hypertension, smoking, alcohol, diabetes, heart disease and lifestyle-related problems are the common causes of stroke in India. Rheumatic heart disease and cerebral venous thrombosis are the main etiologies of stroke in the young in our country.
Recurrent stroke
In an Oxfordshire Community Stroke Project reported in 1994, it was found that actuarial risk of suffering a recurrence was 30% (95% confidence interval, 20% to 39%) by 5 years, about nine times the risk of stroke in the general population. The risk was highest early after the first stroke: 13% (95% confidence interval, 10% to 16%) by 1 year, 15 times the risk in the general population. After the first year, the average annual risk was about 4%.
In the Copenhagen Stroke Study, stroke was recurrent in 23% despite most of these patients being given prophylactic treatment prior to recurrence. Only 12% of patients with atrial fibrillation were receiving anticoagulant treatment prior to recurrence. In multivariate analysis, recurrence was more frequently associated with a history of transient ischemic attack (TIA), atrial fibrillation, male gender, and hypertension, but not with age, daily alcohol consumption, smoking, diabetes, ischemic heart disease, serum cholesterol or hematocrit. Mortality was almost doubled compared with patients with a first-ever stroke. In survivors, however, both neurologic and functional outcomes and the speed of recovery were, in general, similar in the two groups. Despite similar neurologic impairments, patients with recurrence contralateral to their first stroke had markedly more severe functional disability after completed rehabilitation than patients with ipsilateral recurrence, implying that the ability to compensate functionally is decreased in patients with contralateral recurrence.
However, recently the rates of stroke recurrence have changed in developed countries. On average, the annual risk for future ischemic stroke after an initial ischemic stroke or TIA is ≈3% to 4%. Recent clinical trials of patients with non-cardio embolic ischemic stroke suggest the risk may be as low as 3%, but these data probably underestimate the community-based rate. The estimated risk for an individual patient will be affected by specific characteristics of the event and the person, including age, event type, comorbid illness, and adherence to preventive therapy. The current average annual rate of future stroke (≈3%-4%) represents a historical low that is the result of important discoveries in prevention science. These include antiplatelet therapy and effective strategies for the treatment of hypertension, atrial fibrillation, arterial obstruction and hyperlipidemia.
Even in developed nations currently, there are large gaps in the utilization of preventive drugs, control of risk factors, and uptake of lifestyle-changing behaviours. This is often because of failure in the initiation of secondary prevention.
Novel methods to improve the risk factor control to prevent recurrent stroke
In 2017, the number of mobile phone users is forecast to reach 4.77 billion. The number of mobile phone users in the world is expected to pass the five billion mark by 2019. In 2014, nearly 60 per cent of the population worldwide already owned a mobile phone. Mobile phone text messages can be used to remind, encourage, and motivate patients to adhere to secondary prevention strategies, but there has been limited robust scientific evaluation of these interventions.
Recurrent stroke in India
Data on recurrent stroke and its causes are scarce from low and middle-income countries like India. In the door-to-door survey done in Kolkata, 15% of patients had a recurrent stroke.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Study is a multicenter, randomized, parallel-design, adaptive and blinded end-point clinical trial of sub-acute stroke patients
| Arm | Type | Receives |
|---|---|---|
| Structured Semi-Interactive Prevention | Active comparator | Other: Structured Semi-Interactive Stroke Prevention PackageThe intervention arm will receive a Structured Semi-Interactive Stroke Prevention Package including patient workbook, short messaging services and health education videos for a period of one-year in addition to standard of care as per current guidelines |
| Control group | No intervention | –Patients will receive standard post stroke care for 1 year |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 years and above including both men and women
- First-ever Ischemic stroke or intracerebral haemorrhage
- Between 2 days-3 months of stroke symptom onset
- Computed Tomography /Magnetic Resonance Imaging shows recent stroke (infarct and/or hemorrhage)
- Able to read and complete simple tasks suggested in the stroke workbook if having aphasia or is illiterate, a caregiver is available to read for the patients and complete the reading/workbook tasks for the patients.
Key exclusion criteria (7 listed)
- Modified Rankin scale score 0 and 1 at the time of enrollment
- Limited internet and/or mobile accessibility due to travel
- Patients having active malignancies needing intensive therapy
- Patients with a terminal illness with an anticipated lifespan of less than 1 year
- Patients with heart failure admitted more than twice in the last six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Semi-Interactive Stroke Prevention PackageThe intervention arm will receive a Structured Semi-Interactive Stroke Prevention Package including patient workbook, short messaging services and health education videos for a period of one-year in addition to standard of care as per current guidelines. | Other | Structured Semi-Interactive Prevention |
Primary outcome
Cardiovascular event
Time frame: One year.
Primary outcome measure is a composite endpoint of Recurrent Stroke, high-risk Transient Ischemic Attack, Acute Coronary Syndrome and Death.
11 secondary outcomes
Systolic Blood Pressure (mmHg)
Time frame: One year.
Fasting Blood Glucose (mg/dl)
Time frame: One year.
LDL Cholesterol (mg/dl)
Time frame: One year.
Triglycerides (mg/dl)
Time frame: One year.
Smoking cessation (No/ total %)
Time frame: One year.
Alcohol cessation
Time frame: One year.
Body Mass Index (kg/m2)
Time frame: One year.
Physical Activity MET (min/week)
Time frame: One year.
Intervention Non-Compliance Assessment (INCA)
Time frame: One year.
Modified Rankin Scale (mRS)
Time frame: One year.
Diastolic Blood Pressure (mmHg)
Time frame: One year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Background: PubMed 22267690Chow CK, Redfern J, Thiagalingam A, Jan S, Whittaker R, Hackett M, Graves N, Mooney J, Hillis GS. Design and rationale of the tobacco, exercise and diet messages (TEXT ME) trial of a text message-based intervention for ongoing prevention of cardiovascular disease in people with coronary disease: a randomised controlled trial protocol. BMJ Open. 2012 Jan 19;2(1):e000606. doi: 10.1136/bmjopen-2011-000606. Print 2012.
- Background: PubMed 26486857Kamal AK, Shaikh Q, Pasha O, Azam I, Islam M, Memon AA, Rehman H, Akram MA, Affan M, Nazir S, Aziz S, Jan M, Andani A, Muqeet A, Ahmed B, Khoja S. A randomized controlled behavioral intervention trial to improve medication adherence in adult stroke patients with prescription tailored Short Messaging Service (SMS)-SMS4Stroke study. BMC Neurol. 2015 Oct 21;15:212. doi: 10.1186/s12883-015-0471-5.
- Derived from this study: PubMed 40335450Kumaravelu S, Verma SJ, Arora R, Arora D, Arya Devi KS, Dhasan A, Sylaja PN, Khurana D, Vijaya P, Ray B, Nambiar V, Aaron S, Mittal G, Nagarjunakonda S, Pai A, Reddy YM, Narayan S, Borah N, Das R, Kulkarni G, Huded V, Mathew T, Srivastava MVP, Bhatia R, Ojha P, Roy J, Abraham S, Vaishnav A, Sharma A, Jabeen SA, Pathak A, Bhoi S, Sharma S, Sulena S, Saroja AO, Ramrakhiani N, Kempegowda MB, Gorthi S, Kate M, George T, Sebastian I, Sharma M, Dhaliwal R, Huilgol R, Pandian JD. SPRINT INDIA: Regional Variations in Primary and Secondary Stroke Outcomes Based on Baseline Characteristics in North and South Indian Sites. Ann Indian Acad Neurol. 2025 May 1;28(3):378-386. doi: 10.4103/aian.aian_792_24. Epub 2025 May 7.
- Derived from this study: PubMed 40239637Verma SJ, Karuthedathu Mana Sanal Kumar AD, Arora D, Dhasan A, Sylaja PN, Khurana D, Vijaya P, Ray BK, Nambiar V, Aaron S, Mittal GK, Pai AR, Kumaravelu S, Reddy YM, Narayan S, Borah NC, Das R, Kulkarni GB, Huded V, Mathew T, Srivastava P, Bhatia R, Ojha PK, Roy J, Abraham SM, Vaishnav A, Sharma A, Pathak A, Bhoi SK, Sharma S, Sulena S, Saroja AO, Ramrakhiani N, Kempegowda MB, Gorthi SP, Kate MP, George T, Sebastian IA, Sharma M, Dhaliwal R, Huilgol R, Pandian JD. Comparing Stroke Profiles and Outcomes between Urban and Rural India: A Secondary Analysis of the SPRINT INDIA Trial. Cerebrovasc Dis. 2026;55(1):29-39. doi: 10.1159/000545675. Epub 2025 Apr 16.
- Derived from this study: PubMed 36796986SPRINT INDIA trial collaborators. Secondary prevention with a structured semi-interactive stroke prevention package in INDIA (SPRINT INDIA): a multicentre, randomised controlled trial. Lancet Glob Health. 2023 Mar;11(3):e425-e435. doi: 10.1016/S2214-109X(22)00544-7.
- Derived from this study: PubMed 34813082Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
- Derived from this study: PubMed 31852411Kate MP, Arora D, Verma SJ, Sylaja PN, Renjith V, Sharma M, Pandian JD; SPRINT India Collaborators. Secondary Prevention by Structured Semi-Interactive Stroke Prevention Package in India (SPRINT INDIA) study protocol. Int J Stroke. 2020 Jan;15(1):109-115. doi: 10.1177/1747493019895653. Epub 2019 Dec 18.
- Individual participant dataSharing planned: No. All information collected from medical records for the study will be stored electronically in a specifically designed database at the Christian Medical College and Hospital, Ludhiana. Participants information will be identified only by their initials, date of birth and a study registration number. Any information transferred electronically will be coded to protect confidentiality. All computer records will be password protected. The study results may be presented at conferences or in scientific publications, but individual participants will not be identifiable. If needed, data will be available in future for other researchers outside the primary research group for secondary purposes, such as meta-analyses, reanalysis, or replication of results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeyaraj D Pandian, MD DM principal investigator
Christian Medical College and Hospital, Ludhiana, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Semi-Interactive Stroke Prevention Package in people with Stroke, run by Christian Medical College and Hospital, Ludhiana, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeyaraj D Pandian, MD DM (9915784750, jeyarajpandian@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular event (time frame: One year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03228979, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.