Acute Coronary Syndrome Sri Lanka Audit Project

NCT02893280 | Withdrawn DMC

• 1 other identifier: UC00101
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

ACSSLAP is the first island wide audit project in Sri Lanka on ACS.

Conditions

Acute Coronary Syndrome; Unstable Angina; Non ST Elevation Myocardial Infarction; ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Discharge, recovery or death after diagnosed acute coronary syndrome

  Recovery, discharge or death after acute coronary syndrome management following admission to a hospital

  From the diagnosis of acute coronary syndrome up to 4 weeks of the hospital stay

Other Outcomes (2)

• Patient management

  From the diagnosis of acute coronary syndrome up to 4 weeks of the hospital stay

• Health care resources utilization

  From the diagnosis of acute coronary syndrome up to 4 weeks of the hospital stay

Interventions

aspirin, clopidogrel, statin, enoxaparin, streptokinase DRUG

Acute coronary syndrome treatment

Also known as: Alteplase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This audit will be conducted representing the hierarchy of health care delivery system representing tertiary units, teaching hospitals, district general hospitals up to base hospital level where at least a physician is available. Sample size will be considered based on the number of admissions to each hospital. Minimum number from each hospital will be 30. This number was selected as according to International Network on Rational Use of Drugs (INRUD) guidelines of the World Health Organization, a minimum of 30 prescriptions are recommended from each unit and a minimum of 20 units when auditing prescription data to give a minimum of 600 prescription encounters.

You may qualify if:

• Patients who are diagnosed with acute coronary syndrome before/after admission to the hospital.

You may not qualify if:

• Patient who refuse to give consent
• Patients who are less than 18 years of age
• Patients whose diagnosis later changed to another diagnosis
• Patient who are enrolled in any other study.

Sponsors & Collaborators

• University of Colombo: lead
• Ministry of Health, Sri Lanka: collaborator

Study Sites (1)

Faculty of Medicine

Colombo, Western Province, 80200, Sri Lanka

Location

Related Publications (1)

• Amsterdam EA, Wenger NK, Brindis RG, Casey DE Jr, Ganiats TG, Holmes DR Jr, Jaffe AS, Jneid H, Kelly RF, Kontos MC, Levine GN, Liebson PR, Mukherjee D, Peterson ED, Sabatine MS, Smalling RW, Zieman SJ; ACC/AHA Task Force Members. 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Dec 23;130(25):e344-426. doi: 10.1161/CIR.0000000000000134. Epub 2014 Sep 23. No abstract available.

  PMID: 25249585 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome; Angina, Unstable; Non-ST Elevated Myocardial Infarction; ST Elevation Myocardial Infarction

Interventions

Aspirin; Clopidogrel; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enoxaparin; Streptokinase; Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serine Endopeptidases; Serine Proteases; Biological Factors

Study Officials

• Priyadarshani Galappatthy, MD

  Department of Pharmacology, Faculty of Medicine, University of Colombo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Pharmacology and Pharmacy

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 8, 2016
• Study Start: April 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 16, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

SR (1)