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Status:

TERMINATED

A Study of Aspirin and Simvastatin in Pulmonary Arterial Hypertension

Lead Sponsor:

University of Pennsylvania

Collaborating Sponsors:

National Heart, Lung, and Blood Institute (NHLBI)

Conditions:

Hypertension, Pulmonary

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

The purpose of this study is to determine whether aspirin and simvastatin are safe and effective for the treatment of pulmonary arterial hypertension (PAH).

Detailed Description

PAH is characterized by dyspnea, fatigue, and lower extremity edema as a result of heart failure. In PAH, in situ thrombosis may occur in the lungs, and pulmonary endothelial dysfunction is well-recog...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2009

Estimated Enrollment :

64 Patients enrolled

Trial Details

Trial ID

NCT00384865

Start Date

September 1 2006

End Date

October 1 2009

Last Update

July 21 2017

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Johns Hopkins University

Baltimore, Maryland, United States, 21205

2

Tufts University School of Medicine

Boston, Massachusetts, United States, 02110

3

Columbia University

New York, New York, United States, 10032

4

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104