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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00384865 |
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Date of registration:
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30/09/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of Aspirin and Simvastatin in Pulmonary Arterial Hypertension
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Scientific title:
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A Clinical Trial of Aspirin and Simvastatin in Pulmonary Arterial Hypertension |
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Date of first enrolment:
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September 2006 |
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Target sample size:
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64 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00384865 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Steven M Kawut, MD, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Pennsylvania |
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Name:
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Kari E Roberts, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Tufts University |
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Name:
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Reda E Girgis, MB, BCh |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johns Hopkins University |
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Name:
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David J Lederer, MD, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Columbia University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Mean pulmonary artery pressure greater than 25 mm Hg at rest with a pulmonary
capillary wedge pressure less than 16 mm Hg
- Diagnosis of PAH that is a) idiopathic, b) familial, or c) associated with collagen
vascular disease, HIV infection, congenital systemic-to-pulmonary shunt, or former
anorexigen use
- Most recent pulmonary function tests showing FEV1/FVC ratio greater than 50% AND one
of the following conditions: a) total lung capacity greater than 70% predicted, or b)
total lung capacity between 60% and 70% of predicted value with no more than mild
patchy interstitial lung disease on high resolution computerized tomography of the
chest
- Ability to perform six-minute walk testing without limitations in musculoskeletal
function or coordination
- Negative pregnancy test at screening visit for women of childbearing potential
- If female, willing to use adequate form of birth control
Exclusion Criteria:
- PAH related to other etiologies
- Diagnosis of sickle cell disease
- Clinically significant untreated sleep apnea, as diagnosed by polysomnography
- Left-sided valvular disease (more than moderate mitral valve stenosis or insufficiency
or aortic stenosis or insufficiency), pulmonary artery or valve stenosis, or ejection
fraction less than 45% on echocardiography
- Hospitalized or acutely ill
- Kidney failure
- Initiation of PAH therapy (prostacyclin analogues, endothelin [ET]-1 receptor
antagonists, phosphodiesterase [PDE]-5 inhibitors) within 3 months of study entry
- Allergy or hypersensitivity to aspirin or simvastatin
- Absolute indication for aspirin or other anti-platelet therapy
- Current treatment with statin therapy
- Inability or unwillingness to avoid non-steroidal, anti-inflammatory medications for 6
months following study entry
- Current or recent use or planned treatment with one of the following: amiodarone,
cyclosporine, itraconazole, ketoconazole, erythromycin, clarithromycin, HIV protease
inhibitors, nefazodone, cimetidine, danazol, large quantities of grapefruit juice
(more than 1 quart daily), verapamil, fibrates, or niacin
- Peptic or duodenal ulcer diagnosed within 1 year of study entry
- Gastrointestinal bleeding within 6 months prior of study entry
- Bleeding diathesis
- History of intracranial bleeding
- Anemia (hematocrit less than 30%) at screening
- International normalized ratio (INR) greater than 3.0 at screening
- Severe thrombocytopenia (less than 75,000/L) at screening
- Hepatic transaminases greater than twice the upper limit of normal at screening
- Chronic liver disease (e.g., cirrhosis, chronic hepatitis) with portal hypertension
- Current or recent (within 6 months of study entry) chronic heavy alcohol consumption
- History of myositis
- Creatine phosphokinase (CPK) greater than 1.5 times the upper limit of normal at
screening
- Abnormalities of the arm or hand or past radical mastectomy that might prevent
brachial artery ultrasound
- Pregnant or breastfeeding
- Current use of another investigational drug for PAH
- Received a lung transplant
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypertension, Pulmonary
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Intervention(s)
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Drug: Simvastatin
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Drug: Placebo
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Drug: Aspirin
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Primary Outcome(s)
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Distance Walked in Six Minutes
[Time Frame: Measured at 6 months]
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Secondary Outcome(s)
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Adverse Events
[Time Frame: Measured at 6 months]
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Time to Clinical Worsening Events (Number of Events)
[Time Frame: Measured at 6 months]
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Secondary ID(s)
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R01HL082895-01
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458
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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