Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-09-30

Brief Summary

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Sildenafil has shown potential effects both on vasodilator mechanisms and as an inhibitor of the NO/GMPc Pain activation. The investigators aim at estimating the benefit of sildenafil in term of morbi-mortality in patients with arterial claudication on a multicenter prospective double blind study.

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Detailed Description

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Eligible patients will ask to participate after oral and written information. Evaluation of walking capacity (self reported and treadmill measured), co-morbid condition and quality of life (WELCH, SF-36, Edinburg) will be performed at inclusion, after the first dose and at 3 months of oral treatment through sildenafil 100mg/day or placebo from inclusion to 3 months.

Indication for revascularisation will be evaluated at 3 months according to symptoms and walking capacity according to the Rutherford classification.

Primary endpoint is the proportion of patients showing either a fatal events (cardio-vascular or noncardiovascular) or hospitalisation for non fatal cardiovascular events at 6 and 9 months follow up from inclusion.

Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Treated group

Sildenafil, oral, 100mg per day

Group Type ACTIVE_COMPARATOR

Sildenafil

Intervention Type DRUG

100 mg per day

Control group

placebo oral

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo with same presentation as the active drug

Interventions

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Sildenafil

100 mg per day

Intervention Type DRUG

Placebo

Placebo with same presentation as the active drug

Intervention Type DRUG

Other Intervention Names

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Viagra or revatio

Eligibility Criteria

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Inclusion Criteria

* ABI\<0.90
* Vascular type claudication
* stable walking impairment for at least 3 months
* Optimal cardiovasc treatment (Anti-platelet, HMGCoA-Inh, ACE-Inh or AT2 inh)
* Age \> 30 years