Acute Coronary SyndromeACS QUIKNCT02256657
Study of a Quality Improvement Toolkit in Kerala, India, Among Hospitals Treating Acute Coronary Syndrome Patients
A study testing Quality Improvement Toolkit in people with Acute Coronary Syndrome, run by Northwestern University at 63 sites in India.
Trial summary
The trial assesses the effect on 30-day major adverse cardiovascular event (MACE) rate of using a quality improvement toolkit among hospitals in Kerala, India. The quality improvement toolkit includes standardized admission and discharge sets, clinical pathways and an audit and feedback program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Quality Improvement Toolkit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21,374 participants
- Where
- 63 sitesIndia
- Study dates
- Nov 2014to Dec 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presenting with Acute Coronary Syndrome
Who cannot join
- Below the Age of 18
- Patient without Acute Coronary Syndrome
Trial locations and contacts
63 sites in 1 country.
63 sites in 1 country
India63 sites
Government Medical College Alappuzha
Alappuzha, Kerala, 688005
Samaritan Hospital
Aluva, Kerala, 683562
Little Flower Hospital & Research Center
Angamaly, Kerala, 683572
Baby Memorial Hospital
Calicut, Kerala, 673004
Government Medical College Kozhikode
Calicut, Kerala, 673008
Metro International Cardiac Centre
Calicut, Kerala, 673014
Sree Narayana Institute of Medical Sciences
Chalakka, Kerala, 683594
Rajah Charitable Medical Trust
Chāvakkād, Kerala, 680506
KVM Hospital
Cherthala, Kerala, 688524
Sukapuram Hospital
Edappāl, Kerala, 679576
Irinjalakuda Co-operative Hospital Limited
Irinjālakuda, Kerala, 680661
Lal Memorial Hospital
Irinjālakuda, Kerala, 680712
Koyili Hospital
Kannur, Kerala, 670004
St. Martin De Porres Hospital
Kannur, Kerala, 670301
Pariyaram Medical College Hospital
Kannur, Kerala, 670503
Kannur Medical College Super Specialty Hospital
Kannur, Kerala, 670612
Lourdes Hospital
Kochi, Kerala, 682012
Lakshmi Hospital
Kochi, Kerala, 682016
PVS Memorial Hospital
Kochi, Kerala, 682017
Lisie Hospital
Kochi, Kerala, 682018
Indira Ghandi Co-operative Hospital
Kochi, Kerala, 682020
Amrita Institute of Medical Sciences & Research Center
Kochi, Kerala, 682041
Malankara Orthodox Syrian Church Medical College Hospital
Kolenchery, Kerala, 682311
AA Rahim Memorial District Hospital
Kollam, Kerala, 691001
Bishop Benziger Hospital
Kollam, Kerala, 691001
Dr. K. Damodaran Memoral Hospital
Kollam, Kerala, 691001
Holy Cross Hospital
Kollam, Kerala, 691571
Travancore Medical College
Kollam, Kerala, 691589
St. Joseph's Hospital
Kōthamangalam, Kerala, 686691
Malabar Institute of Medical Sciences
Kōttakkal, Kerala, 676503
Bharath Cardiovascular Institute
Kottayam, Kerala, 686001
S.H. Medical Centre Hospital
Kottayam, Kerala, 686001
Government Medical College Kottayam
Kottayam, Kerala, 686008
Caritas Hospital
Kottayam, Kerala, 686630
KMCT Medical College
Kozhikode, Kerala, 673602
C.H. Memorial Hospital
Malappuram, Kerala, 676552
Palakkad Government District Hospital
Palakkad, Kerala, 678001
Thangam Hospital
Palakkad, Kerala, 678004
Lakshmi Hospital
Palakkad, Kerala, 678013
EMS Memorial Hospital
Perintalmanna, Kerala, 679322
Ramdas Clinic & Nursing Home
Perintalmanna, Kerala, 679322
Tellicherry Cooperative Hospital
Thalassery, Kerala, 670101
SK Hospital
Thiruvananthapuram, Kerala, 695006
Medical College Thiruvananthapuram
Thiruvananthapuram, Kerala, 695011
Sree Chitra Institute for Medical Sciences and Technology
Thiruvananthapuram, Kerala, 695011
Ananthapuri Hospital and Research Institute
Thiruvananthapuram, Kerala, 695024
Noorul Islam Institute of Medical Science & Research Foundation
Thiruvananthapuram, Kerala, 695123
Sree Gokulam Medical College & Research Foundation
Thiruvananthapuram, Kerala, 695607
St. Mary's Hospital
Thodupuzha, Kerala, 685584
Santhi Nursing Home
Thrissur, Kerala, 679561
WestFort Hi-Tech Hospital Limited
Thrissur, Kerala, 680002
Jubilee Mission Medical College & Research Institute
Thrissur, Kerala, 680005
Elite Mission Hospital
Thrissur, Kerala, 680007
Mother Hospital Limited
Thrissur, Kerala, 680012
Aswini Hospital
Thrissur, Kerala, 680020
Daya General Hospital & Specialty Surgery Centre
Thrissur, Kerala, 680022
St. James Hospital
Thrissur, Kerala, 680307
Amala Institute of Medical Sciences
Thrissur, Kerala, 680555
Government Medical College Thrissur
Thrissur, Kerala, 680596
Modern Hospital
Thrissur, Kerala, 680664
Pushpagiri Institute of Medical Sciences and Research Centre
Tiruvalla, Kerala, 689101
PRS Hospital
Trivandrum, Kerala, 695002
Kerala Institute of Medical Sciences
Trivandrum, Kerala, 695029
About this study
Official title: Acute Coronary Syndrome Quality Improvement in Kerala (ACS QUIK) Cluster Randomized, Stepped Wedge Multi-center Implementation of a Locally-Developed Quality Improvement Toolkit
The trial assesses the effect on 30-day major adverse cardiovascular event (MACE) rate of using a quality improvement toolkit among hospitals in Kerala, India. The quality improvement toolkit includes standardized admission and discharge sets, clinical pathways and an audit and feedback program.
Read the detailed description
This study is a cluster randomized, stepped wedge clinical trial assessing implementation and effect of a locally-developed quality improvement toolkit for patients with acute coronary syndrome (ACS) in Kerala, India. Hospitals will be randomized after stratification for size to one of five cohorts. After a four-month baseline period, the quality improvement toolkit will be implemented in all hospitals in cohort 1. Through a one-way crossover design, these hospitals will continue to use the quality improvement toolkit through the end of the trial for all acute coronary syndrome (ACS) patients. Cohorts 2 through 5 will implement the quality improvement toolkit at time points 8, 12, 16, and 20 months respectively, continuing the use of the toolkits from that time forward to the end of the study. The primary outcome is 30-day MACE rates, including death, reinfarction stroke, or major bleeding. Rates will be continuously collected and compared at one interim time point for safety and efficacy. Final analysis compares MACE rates before and after implementation of the quality improvement toolkits, accounting for cluster effects of hospital, cohort and time.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Quality Improvement Toolkit
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality Improvement ToolkitBehavioural
The quality improvement toolkit is comprised of standardized admission and discharge checklists, clinical pathways, an audit and feedback mechanism through electronic data capture, and a monthly report used in conjunction with root cause analysis meetings. Quality improvement toolkits are implemented by individual hospitals.
| Study group | Role | What they receive |
|---|---|---|
| Step 1: Toolkit Implemented in Month 4 | Experimental | Quality Improvement Toolkit Receives: Behavioral: Quality Improvement Toolkit |
| Step 2: Toolkit Implemented in Month 8 | Experimental | Quality Improvement Toolkit Receives: Behavioral: Quality Improvement Toolkit |
| Step 3: Toolkit Implemented in Month 12 | Experimental | Quality Improvement Toolkit Receives: Behavioral: Quality Improvement Toolkit |
| Step 4: Toolkit Implemented in Month 16 | Experimental | Quality Improvement Toolkit Receives: Behavioral: Quality Improvement Toolkit |
| Step 5: Toolkit Implemented in Month 20 | Experimental | Quality Improvement Toolkit Receives: Behavioral: Quality Improvement Toolkit |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-Day Major Adverse Cardiovascular Events
Compared with usual care, to evaluate the effect of a locally-developed, evidence-based health care quality improvement toolkit on 30-day major adverse cardiovascular events (MACE [death, reinfarction stroke, or major bleeding]) in patients admitted with acute coronary syndrome, adjusted for hospital, time, and step.
Measured: 30 Days from Hospital Discharge
Secondary outcomes (7)
In-Hospital Medication Rates
Compared with usual care, to evaluate the effect of a locally-developed, evidence-based health care quality improvement toolkit on in-hospital medication prescription rates.
Measured: 30 Days
Discharge Medication Rates
Compared with usual care, to evaluate the effect of a locally-developed, evidence-based health care quality improvement toolkit on discharge medication prescription rates.
Measured: 30 Days
Discharge Advice Relative to Healthy Lifestyles
Compared with usual care, to evaluate the effect of a locally-developed, evidence-based health care quality improvement toolkit on discharge advice relative to healthy lifestyles.
Measured: 30 Days
In-Hospital and 30-Day Expanded MACE
Compared with usual care, to evaluate the effect of a locally-developed, evidence-based health care quality improvement toolkit on in-hospital and 30-day expanded MACE.
Measured: 30 Days
Concordance with locally-defined performance measures and in-hospital and 30-day MACE
To evaluate the association between concordance with locally-defined performance measures for ACS care and in-hospital and 30-day MACE.
Measured: 30 Days
Health Related Quality of Life
To evaluate health related quality of life in post-ACS patients (30-days) using a translated and validated version of the Seattle Angina Questionnaire (SAQ).
Measured: 30 Days
Impoverishing Effects of an ACS Event
To evaluate individual- and household-level impoverishing effects of an ACS event in the context of the recent implementation of a national government insurance program for families below the poverty line.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21,374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Mark Huffman, Northwestern University
- Investigators
- Mark D Huffman, MD, MPH, Principal investigator, Northwestern UniversityPP Mohanan, MD, DM, Study director, WestFort Hi-Tech HospitalDoirairaj Prabhakaran, MD, DM, Study chair, Centre for Chronic Disease ControlDonald Lloyd-Jones, MD, ScM, Study chair, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02256657
- Sponsor's protocol ID
- ACS QUIK
- Other IDs
- 1K99HL107749-01A1, R00HL107749-03
- Acronym
- ACS QUIK
- Status last verified
- Aug 2018
- First submitted
- 1 Oct 2014
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified individual patient data for ACS QUIK will be shared through NHBLI BIOLINCC.
Publications
Huffman MD, Mohanan PP, Devarajan R, Baldridge AS, Kondal D, Zhao L, Ali M, Lloyd-Jones DM, Prabhakaran D. Acute coronary syndrome quality improvement in Kerala (ACS QUIK): Rationale and design for a cluster-randomized stepped-wedge trial. Am Heart J. 2017 Mar;185:154-160. doi: 10.1016/j.ahj.2016.10.026. Epub 2016 Dec 21.
PubMed 28267469Huffman MD, Mohanan PP, Devarajan R, Baldridge AS, Kondal D, Zhao L, Ali M, Krishnan MN, Natesan S, Gopinath R, Viswanathan S, Stigi J, Joseph J, Chozhakkat S, Lloyd-Jones DM, Prabhakaran D; Acute Coronary Syndrome Quality Improvement in Kerala (ACS QUIK) Investigators. Effect of a Quality Improvement Intervention on Clinical Outcomes in Patients in India With Acute Myocardial Infarction: The ACS QUIK Randomized Clinical Trial. JAMA. 2018 Feb 13;319(6):567-578. doi: 10.1001/jama.2017.21906.
PubMed 29450524Pei J, Wang X, Xing Z, Chen P, Su W, Deng S, Hu X. Association between admission systolic blood pressure and major adverse cardiovascular events in patients with acute myocardial infarction. PLoS One. 2020 Jun 19;15(6):e0234935. doi: 10.1371/journal.pone.0234935. eCollection 2020.
PubMed 32559257Huffman MD, Mohanan PP, Devarajan R, Baldridge AS, Kondal D, Zhao L, Ali M, Spertus JA, Chan PS, Natesan S, Abdullakutty J, Krishnan MN, Tp A, Renga S, Punnoose E, Unni G, Prabhakaran D, Lloyd-Jones DM; ACS QUIK Investigators. Health-Related Quality of Life at 30 Days Among Indian Patients With Acute Myocardial Infarction. Circ Cardiovasc Qual Outcomes. 2019 Feb;12(2):e004980. doi: 10.1161/CIRCOUTCOMES.118.004980.
PubMed 30755027Singh K, Devarajan R, Mohanan PP, Baldridge AS, Kondal D, Victorson DE, Karmali KN, Zhao L, Lloyd-Jones DM, Prabhakaran D, Goenka S, Huffman MD; ACS QUIK Investigators. Implementation and acceptability of a heart attack quality improvement intervention in India: a mixed methods analysis of the ACS QUIK trial. Implement Sci. 2019 Feb 6;14(1):12. doi: 10.1186/s13012-019-0857-7.
PubMed 30728053Sarma S, Harikrishnan S, Baldridge AS, Devarajan R, Mehta A, Selvaraj S, Ali MK, Mohanan PP, Prabhakaran D, Huffman MD. Availability, Sales, and Affordability of Tobacco Cessation Medicines in Kerala, India. Circ Cardiovasc Qual Outcomes. 2017 Nov;10(11):e004108. doi: 10.1161/CIRCOUTCOMES.117.004108.
PubMed 29150536
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Coronary Syndrome Quality Improvement in Kerala (ACS QUIK) Cluster Randomized, Stepped Wedge Multi-center Implementation of a Locally-Developed Quality Improvement Toolkit
- ClinicalTrials.gov ID
- NCT02256657
- Acronym / sponsor ID
- ACS QUIK / ACS QUIK
- Conditions
- Acute Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21,374 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Nov 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 3 Oct 2014 (estimated)
- 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.
The trial assesses the effect on 30-day major adverse cardiovascular event (MACE) rate of using a quality improvement toolkit among hospitals in Kerala, India. The quality improvement toolkit includes standardized admission and discharge sets, clinical pathways and an audit and feedback program.
Detailed description
This study is a cluster randomized, stepped wedge clinical trial assessing implementation and effect of a locally-developed quality improvement toolkit for patients with acute coronary syndrome (ACS) in Kerala, India. Hospitals will be randomized after stratification for size to one of five cohorts. After a four-month baseline period, the quality improvement toolkit will be implemented in all hospitals in cohort 1. Through a one-way crossover design, these hospitals will continue to use the quality improvement toolkit through the end of the trial for all acute coronary syndrome (ACS) patients. Cohorts 2 through 5 will implement the quality improvement toolkit at time points 8, 12, 16, and 20 months respectively, continuing the use of the toolkits from that time forward to the end of the study. The primary outcome is 30-day MACE rates, including death, reinfarction stroke, or major bleeding. Rates will be continuously collected and compared at one interim time point for safety and efficacy. Final analysis compares MACE rates before and after implementation of the quality improvement toolkits, accounting for cluster effects of hospital, cohort and time.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Step 1: Toolkit Implemented in Month 4 | Experimental | Behavioral: Quality Improvement ToolkitQuality Improvement Toolkit |
| Step 2: Toolkit Implemented in Month 8 | Experimental | Behavioral: Quality Improvement ToolkitQuality Improvement Toolkit |
| Step 3: Toolkit Implemented in Month 12 | Experimental | Behavioral: Quality Improvement ToolkitQuality Improvement Toolkit |
| Step 4: Toolkit Implemented in Month 16 | Experimental | Behavioral: Quality Improvement ToolkitQuality Improvement Toolkit |
| Step 5: Toolkit Implemented in Month 20 | Experimental | Behavioral: Quality Improvement ToolkitQuality Improvement Toolkit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Presenting with Acute Coronary Syndrome
Key exclusion criteria (2 listed)
- Below the Age of 18
- Patient without Acute Coronary Syndrome
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 |
|---|---|---|
| Quality Improvement ToolkitThe quality improvement toolkit is comprised of standardized admission and discharge checklists, clinical pathways, an audit and feedback mechanism through electronic data capture, and a monthly report used in conjunction with root cause analysis meetings. Quality improvement toolkits are implemented by individual hospitals. | Behavioural | Step 1: Toolkit Implemented in Month 4, Step 2: Toolkit Implemented in Month 8, Step 3: Toolkit Implemented in Month 12, Step 4: Toolkit Implemented in Month 16, Step 5: Toolkit Implemented in Month 20 |
Primary outcome
30-Day Major Adverse Cardiovascular Events
Time frame: 30 Days from Hospital Discharge
Compared with usual care, to evaluate the effect of a locally-developed, evidence-based health care quality improvement toolkit on 30-day major adverse cardiovascular events (MACE [death, reinfarction stroke, or major bleeding]) in patients admitted with acute coronary syndrome, adjusted for hospital, time, and step.
7 secondary outcomes
In-Hospital Medication Rates
Time frame: 30 Days
Discharge Medication Rates
Time frame: 30 Days
Discharge Advice Relative to Healthy Lifestyles
Time frame: 30 Days
In-Hospital and 30-Day Expanded MACE
Time frame: 30 Days
Concordance with locally-defined performance measures and in-hospital and 30-day MACE
Time frame: 30 Days
Health Related Quality of Life
Time frame: 30 Days
Impoverishing Effects of an ACS Event
Time frame: 30 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Background: PubMed 28267469Huffman MD, Mohanan PP, Devarajan R, Baldridge AS, Kondal D, Zhao L, Ali M, Lloyd-Jones DM, Prabhakaran D. Acute coronary syndrome quality improvement in Kerala (ACS QUIK): Rationale and design for a cluster-randomized stepped-wedge trial. Am Heart J. 2017 Mar;185:154-160. doi: 10.1016/j.ahj.2016.10.026. Epub 2016 Dec 21.
- Results publication: PubMed 29450524Huffman MD, Mohanan PP, Devarajan R, Baldridge AS, Kondal D, Zhao L, Ali M, Krishnan MN, Natesan S, Gopinath R, Viswanathan S, Stigi J, Joseph J, Chozhakkat S, Lloyd-Jones DM, Prabhakaran D; Acute Coronary Syndrome Quality Improvement in Kerala (ACS QUIK) Investigators. Effect of a Quality Improvement Intervention on Clinical Outcomes in Patients in India With Acute Myocardial Infarction: The ACS QUIK Randomized Clinical Trial. JAMA. 2018 Feb 13;319(6):567-578. doi: 10.1001/jama.2017.21906.
- Derived from this study: PubMed 32559257Pei J, Wang X, Xing Z, Chen P, Su W, Deng S, Hu X. Association between admission systolic blood pressure and major adverse cardiovascular events in patients with acute myocardial infarction. PLoS One. 2020 Jun 19;15(6):e0234935. doi: 10.1371/journal.pone.0234935. eCollection 2020.
- Derived from this study: PubMed 30755027Huffman MD, Mohanan PP, Devarajan R, Baldridge AS, Kondal D, Zhao L, Ali M, Spertus JA, Chan PS, Natesan S, Abdullakutty J, Krishnan MN, Tp A, Renga S, Punnoose E, Unni G, Prabhakaran D, Lloyd-Jones DM; ACS QUIK Investigators. Health-Related Quality of Life at 30 Days Among Indian Patients With Acute Myocardial Infarction. Circ Cardiovasc Qual Outcomes. 2019 Feb;12(2):e004980. doi: 10.1161/CIRCOUTCOMES.118.004980.
- Derived from this study: PubMed 30728053Singh K, Devarajan R, Mohanan PP, Baldridge AS, Kondal D, Victorson DE, Karmali KN, Zhao L, Lloyd-Jones DM, Prabhakaran D, Goenka S, Huffman MD; ACS QUIK Investigators. Implementation and acceptability of a heart attack quality improvement intervention in India: a mixed methods analysis of the ACS QUIK trial. Implement Sci. 2019 Feb 6;14(1):12. doi: 10.1186/s13012-019-0857-7.
- Derived from this study: PubMed 29150536Sarma S, Harikrishnan S, Baldridge AS, Devarajan R, Mehta A, Selvaraj S, Ali MK, Mohanan PP, Prabhakaran D, Huffman MD. Availability, Sales, and Affordability of Tobacco Cessation Medicines in Kerala, India. Circ Cardiovasc Qual Outcomes. 2017 Nov;10(11):e004108. doi: 10.1161/CIRCOUTCOMES.117.004108.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for ACS QUIK will be shared through NHBLI BIOLINCC.
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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.
Mark D Huffman, MD, MPH principal investigator
Northwestern University
PP Mohanan, MD, DM study director
WestFort Hi-Tech Hospital
Doirairaj Prabhakaran, MD, DM study chair
Centre for Chronic Disease Control
63 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality Improvement Toolkit in people with Acute Coronary Syndrome, run by Northwestern University at 63 sites 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-Day Major Adverse Cardiovascular Events (time frame: 30 Days from Hospital Discharge). 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 NCT02256657, which also lists 6 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 17 Aug 2018; AzTrials last refreshed its copy on 7 Nov 2026.