Mild to moderate intermittent claudication: the clinical and cost-effectiveness of supervised exercise programmes and Cilostazol therapy in patient management - Intermittent claudication: exercise and cilostazol trial (INEXACT)

• Conditions: Intermittent claudication

• Registration Number: EUCTR2005-002327-13-GB
• Lead Sponsor: Heart of England NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-27
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Intermittent claudication as the exercise limiting diagnosis
2. A maximum walking distance of 20-500m (as measured by Treadmill Walking Test)
3. Patient must not have inflow disease requiring intervention
4. Patient must not have any other medical condition that may prevent participation in exercise classes
5. Patient suitable for treatment with cilostazol
6. Patient capable and willing to give fully informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Exercise limited by condition other than intermittent claudication
2. Supra-inguinal arterial disease requiring intervention
3. Presence of other medical condition that may prevent participation in exercise classes
4. Patient having suffered an MI, TIA, CVA or PTCA within 3 months prior to recruitment
5. Patient unsuitable for treatment with cilostazol. Cilostazol treatment is contraindicated in patients:
with creatinine clearance rate <25 ml/min
with congestive heart failure
taking CYP3A4 or CYP2C19 inhibitors (e.g. cimetidine, diltiazem, erythromycin, ketoconazole, lansoprazole, omeprazole and HIV-1 protease inhibitors)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified