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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-07

Study Completion Date

2022-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cerebrovascular Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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CASE

patients experiencing a recurrent stroke while on ASA therapy

TXB2 assay of serum , and 11-dehydro-TXB2 assay of urine

Intervention Type DIAGNOSTIC_TEST

Blood samples are analyzed for the assay of serum TXB2, and urine samples for the assay of 11-dehydro-TXB2

CONTROL

ASA-naïve patients experiencing a first atherothrombotic stroke

TXB2 assay of serum , and 11-dehydro-TXB2 assay of urine

Intervention Type DIAGNOSTIC_TEST

Blood samples are analyzed for the assay of serum TXB2, and urine samples for the assay of 11-dehydro-TXB2

Interventions

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TXB2 assay of serum , and 11-dehydro-TXB2 assay of urine

Blood samples are analyzed for the assay of serum TXB2, and urine samples for the assay of 11-dehydro-TXB2

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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 Criteria

1. Transient ischemic attack (TIA)
2. Chronic treatment with non-steroidal anti-inflammatory drugs (if occasional, not within 4 days prior to hospitalization)
3. Current treatment with oral or parental anticoagulants at prophylactic or therapeutic doses
4. Current treatment with other antiplatelet agents
5. Thrombolysis and thrombectomy
6. Cardio-embolic stroke CENTRO STUDI FONDAZIONE FADOI Page 10 Studio FADOI.01.2018 Versione 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 alanine aminotransferase level 3 times or more and/or bilirubin level 2 times or more higher than 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 carcinoma and 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 despite antihypertensive treatment)
15. Chronic inflammatory bowel disease
16. Chronic treatment with corticosteroid drugs (for example Prednisone \>5 mg/die or equivalent)
17. Pregnancy (in case of child-bearing potential inclusion will be possible in case of negative pregnancy test)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No