SAPhIRE Statin Adverse Drug Reaction

NCT03042286 | Unknown

• 1 other identifier: 2014/00856
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

To find out the pharmacokinetic and genetic risk factors involved in muscular side effects (myalgia) associated with statin therapy. To learn better ways of identifying risk factors associated with muscle side effects during statin therapy. To perform laboratory analysis to identify factors predicting future outcomes. The genetic material, in combination with other medical information and blood tests, will be available to researchers studying genetic and other factors that contribute to myalgia caused in some patient population on statin medication. Patients on statin are selected for this study. This study will recruit 1500 subjects from National heart Centre Singapore over a period of 2.5 years. Participation in the full study includes the donation of genetic material. However, subjects have the option of not having blood subjected to genetic analysis and still participate in the study. In this case, blood samples will only be analyzed for the statin drug content.

Conditions

Myopathy

Keywords

statin; myalgia; myopathy; adverse drug reactions (ADRs); pharmacokinetics and pharmacogenetics

Outcome Measures

Primary Outcomes (1)

• Statin drug and metabolite measurement

  Multiple reaction monitoring via a triple quadropole mass spectrometry (MS) platform

  3 to 6 hours

Secondary Outcomes (1)

• Pharmacogenomics associated with statin

  3 to 6 hours

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatient and outpatient clinics

You may qualify if:

• For myopathy cohort:
• Subjects are/were on any statin drugs at any dose
• Subjects reported/ diagnosed with myopathy =10X normal CK levels
• Myopathy in subjects were statin induced
• For myalgia cohort:
• Subjects are on either Simvastatin or Atorvastatin
• If subject experience muscle symptoms without CK elevation (myalgia), it should be statin induced
• Compliance to five consecutive statin doses prior to sample collection
• For the myalgia subgroup (n=30) for intra-individual variability assessment:
• Subjects are on either Simvastatin or Atorvastatin
• If subject experience muscle symptoms without CK elevation (myalgia), it should be statin induced
• Subjects are willing to provide two blood samples during each of the 3 separate visits
• Compliance to five consecutive statin doses prior to sample collection

You may not qualify if:

• \. Unable or unwilling to give written informed consent 2. Subjects who are pregnant or breast feeding

Sponsors & Collaborators

• National Heart Centre Singapore: lead
• National University Hospital, Singapore: collaborator

Study Sites (1)

National Heart Centre Singapore

Singapore, 169609, Singapore

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

For patients who are sensitive about having genetic material collected, investigators will provide the option of not having their DNA analyzed in the informed consent form.

MeSH Terms

Conditions

Muscular Diseases; Myalgia; Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders

Study Officials

• Dr Wei Chieh Jack Tan

  National Heart Centre Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Wei Chieh Jack Tan

CONTACT

67048892

Katherina Oh

CONTACT

67042290

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: February 3, 2017
• Study Start: March 1, 2015
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: October 18, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)