Clinical study to investigate whether in patients with peripheral artery disease, after implantation of a stent and showing high platelet reactivity during treatment with clopidogrel, treatment with ticagrelor is able to prevent effectively vascular occlusio

Phase 1

• Conditions: peripheral artery disease (PAD); Therapeutic area: Not possible to specify

• Registration Number: EUCTR2014-001989-97-AT
• Lead Sponsor: OA Doz. Dr. Thomas Müller c/o B&S Zentrallabor Konventhospital Barmherzige Brüder Linz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-13
• Last Update Posted: 14 May 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1.)written consent to participate after previous sufficient written and oral information (informed consent)
2.)arteriosclerotic PAD (Fontaine stages II – IV or Rutherford stages 1 – 6)
3.)implantation of a bare-metal stent into the Arteria femoralis superficialis of at least one leg one day ago (first intervention at this vessel)
4.)Proper intake of Plavix ® since stent implantation (including routine intake of one Plavix ® film-coated tablet à 75mg clopidogrel in the morning immediately before inclusion in the clinical trial)
5.)suspected availability within the one-year period of the study participation (out-patient care)
6.)suspected discharge from the hospital within a week after stent implantation
7.)caucasian appearance
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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

1.)non-completion of the 18th year of life
2.)detention (for a court or administrative order), accommodation (in accordance with the Placement Act) or (already performed or initiated) appointment of a custodian
3.)incapability
4.)military service
5.)pregnancy and non-exclusion of pregnancy (women of childbearing potential)
6.)risk of pregnancy occurrence during the test participation
7.)lactation
8.)(with the exception of taking ASS up to 150 mg daily) intake of other TAH than clopidogrel since stent implantation
9.)(with the exception of maintaining a long-term therapy with ASS up to 150 mg daily) foreseeable need for intake of further TAH within the one-year period of study participation
10.)contraindication for Plavix ® or Brilique ® administration
a.hypersensitivity to any component of Plavix ® or Brilique ®
b.acute pathological bleeding e.g. at peptic ulcer or intracranial bleeding
c.intracranial hemorrhage in history
d.moderate to severe hepatic impairment
e.use of CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir and atazanavir)
11.)bypass surgery and / or stent implantation into the affected vessel in history
12.)intake of anticoagulants (vitamin K antagonists or new direct oral anticoagulants such as dabigatran, rivaroxaban or apixaban) in the last week
13.)suspected demand of taking anticoagulants (vitamin K antagonists or new direct oral anticoagulants such as dabigatran, rivaroxaban, apixaban or) within the one-year period of study participation
14.)myocardial infarction (STEMI or NSTEMI) or acute ischemic stroke in the last 30 days
15.)acute or non-arteriosclerotic PAOD (e.g. arterial thrombotic or embolic event, thromboangiitis obliterans, vasculitis, congenital or metabolic vascular disease, etc.)
16.)malignant neoplasm (status post or existing)
17.)platelets <100 G/L
18.)hematocrit <30% or> 52%
19.)uremia or glomerular filtration rate <30ml/min/1. 73m ²
20.)liver cirrhosis or bilirubin> 2mg/dl or GPT and / or GOT> 1.5 of the upper reference value
21.)simultaneous participation in another clinical study with insurance coverage

Study & Design

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