EUCTR2014-001989-97-AT
Active, not recruiting
Phase 1
Clinical study to investigate the efficiency of vascular occlusion prevention by ticagrelor after stent implantation in patients with peripheral artery disease (PAD) and high platelet reactivity during treatment with clopidogrel
OA Doz. Dr. Thomas Müller c/o B&S Zentrallabor Konventhospital Barmherzige Brüder Linz0 sites500 target enrollmentJune 13, 2014
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- OA Doz. Dr. Thomas Müller c/o B&S Zentrallabor Konventhospital Barmherzige Brüder Linz
- Enrollment
- 500
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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