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What is the primary objective of this study?

The purpose of this study is to determine whether simvastatin is effective in reducing the frequency and intensity of vaso-occlusive pain episodes in patients with sickle cell disease.

Who is eligible to participate?

Inclusion Criteria: - Sickle cell disease (HbSS or S/β0 thalassemia) - ≥ 3 vaso-occlusive pain episodes in the year prior to enrollment - Age ≥ 10 years - Weight > 30 kg Exclusion Criteria: - Creatine kinase (CK) > UNL - Total cholesterol < 90 mg/dL, or triglycerides <30mg/dL - Renal dysfunction (Creatinine > 1.5-fold UNL) - Hepatic dysfunction (ALT > 2-fold UNL) - Treatment with drugs having known metabolic interactions with statins within the past 30 days - Vaso-occlusive pain requiring hospitalization within past 30 days - Red blood cell transfusion within the past 30 days - Pregnancy/lactation - Musculoskeletal disorder associated with an elevated CK level - Past or present history of substance abuse (alcohol, cocaine, amphetamines, heroin) - Chronic pain caused by avascular necrosis of the bone (AVN) or leg ulcers, and pain due to trauma or causes other than SCD. - Major cognitive or neurological impairments that may hamper the ability to use the smartphone or complete the electronic pain diary in this study

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Sickle Cell Disease

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Simvastatin40 mg, orally, once daily for 3 months

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

simvastatinSimvastatin (Zocor), 40mg tablet, 40mg orally once daily, for 3 months

Study Status

Completed

Start Date: February 2012

Completed Date: June 2015

Phase: Phase 1/Phase 2

Type: Interventional

Design:

Primary Outcome: Change in Frequency of Vaso-occlusive Pain Events, Before and After Treatment With Simvastatin

Secondary Outcome: Change in Plasma High Sensitivity C-reactive Protein

Study sponsors, principal investigator, and references

Principal Investigator: Carolyn Hoppe, MD

Lead Sponsor:

Collaborator: University of California, Los Angeles

More information:https://clinicaltrials.gov/show/NCT01702246

Hoppe C, Kuypers F, Larkin S, Hagar W, Vichinsky E, Styles L. A pilot study of the short-term use of simvastatin in sickle cell disease: effects on markers of vascular dysfunction. Br J Haematol. 2011 Jun;153(5):655-63. doi: 10.1111/j.1365-2141.2010.08480.x. Epub 2011 Apr 8.