Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT01207700 |
Date of registration:
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22/09/2010 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Secondary Prevention of coRonary Events After Discharge From Hospital (SPREAD)
SPREAD |
Scientific title:
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A Randomized, Open Trial Comparing Post Discharge Interventions to Standard Care |
Date of first enrolment:
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August 2011 |
Target sample size:
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806 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT01207700 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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Dr. Rajeev Gupta, MD, PHD |
Address:
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Telephone:
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Email:
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Affiliation:
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Fortis Escorts Hospital, Jaipur |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Consenting patients being discharged after an acute coronary event such as unstable
angina, acute myocardial infarction, or after coronary intervention (CABG surgery or
PCI).
Exclusion Criteria:
- Patients with other terminal/ debilitating illness, (e.g., advanced cancer, disabling
stroke) those not expected to survive for the study duration, those with dementia and
psychiatric illness or patients unlikely to comply with study requirements, including
regular follow up
Age minimum:
45 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Coronary Syndrome
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Intervention(s)
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Behavioral: CHW based intervention post ACS
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Primary Outcome(s)
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To determine the feasibility of conducting a secondary prevention trial using CDCHWs on adherence to medications and lifestyle advice
[Time Frame: 12 MONTHS]
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To obtain estimates of rates of adherence to pharmacotherapy and lifestyle modification interventions and the incidence of major cardiovascular events
[Time Frame: 12 months]
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Secondary ID(s)
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NO1-HV-98215/SJRI - DCT/SPREAD
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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