Why Does Aspirin Fail in Secondary Cerebrovascular Prevention? A Multicenter Prospective Case - Control Study

Last updated: February 9, 2022
Sponsor: Fadoi Foundation, Italy
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Neurologic Disorders

Atherosclerosis

Treatment

N/A

Clinical Study ID

NCT05247931
FADOI.01.2018
  • Ages > 18
  • All Genders

Study Summary

Multicenter prospective observational case-control study aimed at characterizing the possible determinants of treatment failure in patients with cerebrovascular disease on secondary prevention with ASA, who are hospitalized in Internal Medicine departments for a recurrent atherothrombotic stroke.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years
  2. Swallow-test positive
  3. Patients hospitalized for a first event of athero-thrombotic stroke (CONTROL group)
  4. Patients hospitalized for a recurrence of athero-thrombotic stroke on ASA therapy (CASE group)
  5. Informed Consent

Exclusion

Exclusion Criteria:

  1. Transient ischemic attack (TIA)
  2. Chronic treatment with non-steroidal anti-inflammatory drugs (if occasional, notwithin 4 days prior to hospitalization)
  3. Current treatment with oral or parental anticoagulants at prophylactic or therapeuticdoses
  4. Current treatment with other antiplatelet agents
  5. Thrombolysis and thrombectomy
  6. Cardio-embolic stroke CENTRO STUDI FONDAZIONE FADOI Page 10 Studio FADOI.01.2018Versione n. 2 del 26/09/2019
  7. Carotid stenosis >70%, with indication for revascularization
  8. Current treatment with ASA (only for patients in the CONTROL group)
  9. Acute hepatitis, chronic active hepatitis, liver cirrhosis - or alanineaminotransferase level 3 times or more and/or bilirubin level 2 times or more higherthan the upper limit of the normal range
  10. Thrombocytopenia (<150000 platelets/μl)
  11. Renal failure (eGFR <30 ml/min)
  12. Active cancer or disease in complete remission <1 year, except squamous cell carcinomaand basal-cell carcinoma of the skin at initial stage
  13. Severe chronic obstructive pulmonary disease (COPD) (oxygen therapy)
  14. Uncontrolled hypertension (systolic BP >180 mmHg or diastolic BP >100 mmHg despiteantihypertensive treatment)
  15. Chronic inflammatory bowel disease
  16. Chronic treatment with corticosteroid drugs (for example Prednisone >5 mg/die orequivalent)
  17. Pregnancy (in case of child-bearing potential inclusion will be possible in case ofnegative pregnancy test)

Study Design

Total Participants: 100
Study Start date:
November 07, 2019
Estimated Completion Date:
April 30, 2022

Connect with a study center

  • Ospedale di Assisi

    Assisi,
    Italy

    Active - Recruiting

  • Ospedale Maggiore di Bologna

    Bologna,
    Italy

    Site Not Available

  • Ospedale "S. Cuore di Gesù" Gallipoli

    Gallipoli,
    Italy

    Site Not Available

  • Ospedale Vito Fazzi

    Lecce,
    Italy

    Site Not Available

  • Ospedale Di Mantova

    Mantova,
    Italy

    Site Not Available

  • ASST Grande Ospedale Metropolitano Niguarda

    Milano,
    Italy

    Site Not Available

  • P.O. Ostuni-Fasano - ASL BR

    Ostuni,
    Italy

    Site Not Available

  • IRCCS Mondino

    Pavia,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Santa Maria della Misericordia

    Perugia,
    Italy

    Active - Recruiting

  • Ospedale di Pordenone

    Pordenone,
    Italy

    Site Not Available

  • Policlinico Gemelli

    Roma,
    Italy

    Active - Recruiting

  • Ospedale Umberto I - ASP Siracusa

    Siracusa,
    Italy

    Active - Recruiting

  • Ospedale Molinette

    Torino,
    Italy

    Active - Recruiting

  • Ospedale Ca' Foncello di Treviso

    Treviso,
    Italy

    Site Not Available

  • Ospedale di Circolo -ASST Settelaghi

    Varese,
    Italy

    Site Not Available

  • Ospedale Dei Colli

    Viterbo,
    Italy

    Site Not Available

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