Sildenafil (Viagra) Treatment of Subacute Ischemic Stroke

Terminated

Phase 1 Results N/A

Eligibility 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.