Sildenafil (Viagra) Treatment of Subacute Ischemic Stroke

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Stroke is the third leading cause of death in the United States and the leading cause of serious long-term disability. Approximately 50% of the 750,000 people affected by stroke each year have residual physical impairment. Treatment options for recovery are limited at this time. Sildenafil (Viagra) has demonstrated the capability of significantly improving recovery in several animal experiments of stroke. This study is aiming to establish the safety of treatment with sildenafil in people with stroke with the ultimate aim of testing its usefulness to improve recovery.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henry Ford Health System
• Treatments: Sildenafil Citrate

Criteria

Inclusion Criteria:

• Patients with ischemic stroke between 4 and 7 days after symptom onset.

• Patients age 18-80 years old.

• NIHSS score of 5-21 prior to treatment (within each cohort, there will be no more than 4 patients with NIHSS < 9 and no fewer than 4 patients with NIHSS > 11).

• Signed IRB-approved informed consent by patient or authorized representative.

Exclusion Criteria:

General:

• Participation in another study with an investigational drug or device.

• Women known to be pregnant, lactating, or of childbearing potential with a positive urine beta-HCG.

• Patients who cannot receive oral medications.

• Patients using sildenafil or other phosphodiesterase inhibitors within the previous 7 days of stroke.

Safety Related:

• Unstable angina.

• Myocardial infarction within 3 months.

• Current use of nitrate agents.

• Current use of alpha-channel antagonists.

• Current use of medications that inhibit the cytochrome p450 3A4 system. These medications include: amiodarone, aprepitant, bosentan, cimetidine, cisapride, clarithromycin, delavirdine, diltiazem, efavirenz, erythromycin, fluconazole, fluvoxamine, grapefruit juice, imatinib, itraconazole, ketoconazole,loratadine, mibefradil, mifepristone (RU-486), niacin, nefazodone, quinidine, quinine, ritonavir, saquinavir, tacrolimus, verapamil, voriconazole.

• St. John's Wort and phenytoin (inducers of cytochrome P450 3A4)

• Baseline systolic blood pressure less than 100 mmHg.

• Penile deformities.

• Creatinine > 1.5.

• Abnormal liver function studies.

• Patients with a previous history of sudden monocular vision loss Potentially Interfering with Outcomes Assessment:

• Prior history of dementia.

• Patients without fixed address or those deemed unlikely to present for follow-up by the investigator.

• Patients whose life expectancy is less than 90 days.

• Pre-stroke modified Rankin score > 2.

• Glucose greater than or equal to 400 mg/dL at presentation.

• Other serious illness (e.g., severe hepatic, cardiac, or renal failure; acute myocardial infarction; or a complex disease that may confound treatment assessment).

• Previous stroke or TIA within 30 days.

• Allergy or hypersensitivity to sildenafil or other phosphodiesterase inhibitors.

• History of sudden monocular visual disturbance.

• History of sudden unilateral hearing problem.

Imaging Related:

• Evidence of primary intraparenchymal hemorrhage on initial neuroimaging study.

• Neuroimaging evidence of nonvascular cause for the neurological symptoms.