peripheral artery disease (PAD)
Conditions
Interventions
Trade Name: Plavix 75mg
Pharmaceutical Form: Tablet
INN or Proposed INN: CLOPIDOGREL
Other descriptive name: CLOPIDOGREL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration num
Sponsors
OA Doz. Dr. Thomas Müller c/o B&S Zentrallabor Konventhospital Barmherzige Brüder Linz
Eligibility
Sex/Gender
All
Inclusion 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 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
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 52% 19.) uremia or glomerular filtration rate 2mg/dl or GPT and / or GOT> 1.5 of the upper reference value 21.) simultaneous participation in another clinical study with insurance coverage
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of the effects of ticagrelor intake and the effects of clopidogrel intake on the time to occurrence of in-stent restenosis> 50%;Secondary Objective: Comparison of the effects of ticagrelor intake and the effects of clopidogrel intake on the time to occurrence of myocardial infarction (STEMI or NSTEMI), acute ischemic stroke or death;Primary end point(s): (1) time from stent implantation to in-stent restenosis to> 50% [days] (2) time from stent implantation to myocardial infarction (STEMI or NSTEMI), acute ischemic stroke and/or death [days];Timepoint(s) of evaluation of this end point: E1 until occurrence of the event E1 = examination immediately after patient enrollment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • myocardial infarction (STEMI or NSTEMI), acute ischemic stroke and/or death between E1 and incl. E3 • myocardial infarction (STEMI or NSTEMI), acute ischemic stroke and/or death between E1 and incl. E2 • in-stent restenosis > 50% [yes/no] between E1 and incl. E3 • in-stent restenosis > 50% [yes/no] between E1 and incl. E2 • myocardial infarction (STEMI or NSTEMI) [yes/no] between E1 and incl. E3 • myocardial infarction (STEMI or NSTEMI) [yes/no] between E1 and incl. E2 • STEMI [yes/no] between E1 and incl. E3 • STEMI [yes/no] between E1 and incl. E2 • NSTEMI [yes/no] between E1 and incl. E3 • NSTEMI [yes/no] between E1 and incl. E2 • acute ischemic stroke [yes/no] between E1 and incl. E3 • acute ischemic stroke [yes/no] between E1 and incl. E2 • death [yes/no] between E1 and incl. E3 • death [yes/no] between E1 and incl. E2 E1 = examination immediately after patient enrollment E2 = examination after ½ year E3 = examination after 1 year (termination of patient’s study participation) ;Timepoint(s) of evaluation of this end point: E2 and E3 E2 = examination after ½ year E3 = examination after 1 year (termination of patient’s study participation) | — |
Countries
Austria
Contacts
Public ContactOö. Patientenvertretung
Oö. Patientenvertretung
Outcome results
None listed