Pharmacological modulation of inflammation and platelet activation in inflammatory bowel diseases

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002143-29-IT

Enrollment

Registered

2013-06-06

Start date

2013-08-03

Completion date

Unknown

Last updated

2018-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Trade Name: cardioaspirin 100 Pharmaceutical Form: Compressed lozenge

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Will be including in this study patients of both sexes, with RCU or MC in remission or mild clinical activity, over the age of 18 years 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 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4

Exclusion criteria

Exclusion criteria: Indication for cardiovascular prevention with aspirin and other antiplatelet agents, contraindications or allergy to aspirin, allergic asthma, pregnancy, smoking, uncontrolled hypercholesterolemia, renal disease (creatinine over 2 mg/dl), uncontrolled hypertension, skin and mocous bleeding history, thrombocytopenia (PLT < 60000/µl), severe anemia (Hb < 8 g/dl), coagulation disorders, gastritis, peptic ulcer disease history, gastroesophageal reflux disease, esophageal and / or gastroduodenal sites of disease, previous gastrointestinal surgery, biologic drug treatment, methotrexate, azathioprine or other immunosuppressive agents, coxibs and NSAIDs treatment. Analgesic acetaminophen will be allowed, at doses not exceeding 500 mg twice a day. It will also be permitted 5-aminosalicylic acid (mesalamine) administration. Steroid-resistant or steroid-dependent patients will be excluded.

Design outcomes

Primary

Measure	Time frame
Main Objective: investigate in patients with inflammarory bowel diseases the existence of a state of platelet activation in vivo, its contribution to chronic inflammation and its possible pharmacological modulation by low dose aspirin.;Secondary Objective: nd;Primary end point(s): Will be used biochemical end-points, serum TXB2 and urinary 11-dehydro-TXB2, the main in vitro and in vivo markers of thromboxane-dependent platelet activation respectively.;Timepoint(s) of evaluation of this end point: 14 days	—

Measure

Time frame

Main Objective: investigate in patients with inflammarory bowel diseases the existence of a state of platelet activation in vivo, its contribution to chronic inflammation and its possible pharmacological modulation by low dose aspirin.;Secondary Objective: nd;Primary end point(s): Will be used biochemical end-points, serum TXB2 and urinary 11-dehydro-TXB2, the main in vitro and in vivo markers of thromboxane-dependent platelet activation respectively.;Timepoint(s) of evaluation of this end point: 14 days

—

Secondary

Measure	Time frame
Secondary end point(s): na;Timepoint(s) of evaluation of this end point: na	—

Countries

Italy

Contacts

Public ContactMEDICINA INTERNA E GASTROENTEROLOGI

POLICLINICO GEMELLI

39063503310

Outcome results