Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT04896203
Eligibility Criteria:
Inclusion Criteria:
* Patients over 18 years old
* Patients diagnosed with UC according to ECCO criteria, in ambulatory follow-up in the IBD unit, stratified in remission and mild or moderate ambulatory management activity, determined by clinical (Simple Clinical Colitis Activity Index: SCCAI), biological (fecal calprotectin: CF), and/or endoscopic (Mayo Index) criteria: Remission: defined as a SCCAI \< 2 and/or CF \< 150 and/or May 0 index Activity: defined as an SCCAI \>2, and/or CF \> 150, and/or May Index \>= 1 and \<3.
* Patients diagnosed with CD according to ECCO criteria, in ambulatory follow-up in the IBD unit, stratified according to remission and mild or moderate ambulatory management activity, determined by clinical criteria (Harvey-Bradshaw index: HBI), biological criteria (CF) and/or endoscopic criteria (Simple Endoscopic Score-CD: SES-CD):
Remission: HBI \< 5, and/or CF \< 150, and/or SES CD \< 3. Activity: HBI \>=6 and \<16, and/or CF \> 150, and/or SES-CD \>=3 (\>4 if isolated ileal affectation) and \<=15.
Exclusion Criteria:
* Patients with a previous history of venous or arterial thromboembolism
* Patients with recent hospitalization or surgery in the last 3 months.
* Women who are pregnant, undergoing treatment with oral contraceptives or who have received oral contraceptives in the last 3 months.
* Patients undergoing anticoagulation and/or active antiaggregation treatment
* Patients with severe activity criteria
* Patients with other concomitant conditions that favor thrombosis events
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04896203
Study Brief:
Protocol Section:
NCT04896203