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Clinical Trials/EUCTR2005-000960-25-GB
EUCTR2005-000960-25-GB
Active, not recruiting
Phase 1

Role of Inflammation and Platelet Activation in the adverse Cardiovascular Outcomes of Patients with Critical Limb Ischaemia - a double-blind randomised trial of Clopidogrel. - Platelet activation and Clopidogrel in Critical Limb Ischaemia

othian NHS trust0 sites200 target enrollmentApril 5, 2005
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ConditionsPeripheral Vascular Disease (Critical Limb Ischaemia)
DrugsPlavix

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Peripheral Vascular Disease (Critical Limb Ischaemia)
Sponsor
othian NHS trust
Enrollment
200
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 5, 2005
End Date
July 23, 2009
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
othian NHS trust

Eligibility Criteria

Inclusion Criteria

  • •Patients aged 40\-80 years scheduled for infra\-inguinal lower limb revascularisation or amputation for critical limb ischaemia will be recruited into the trial. Critical limb ischemia will be defined as breakdown of the skin (ulcer or gangrene) and/or pain in the foot even at rest as a result of arterial disease.
  • •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

  • •Non\-atherosclerotic vascular disease
  • •Sudden acute limb ischaemia requiring emergency surgery within a few hours
  • •Patients scheduled for supra\-inguinal or aortic surgery
  • •Acute coronary syndrome within 3 months before surgery
  • •Current active bleeding (e.g. peptic ulcer disease)
  • •Previous or current intracranial haemorrhage
  • •Plan for epidural or spinal anaesthesia
  • •Bleeding diathesis
  • •Uncontrolled hypertension
  • •Thrombocytopenia

Outcomes

Primary Outcomes

Not specified

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