Uncomplicated Peptic Ulcer Clinical Trial
Official title:
The Risk of Uncomplicated Peptic Ulcer in a Cohort of Secondary Prevention Aspirin Users
| Verified date | June 2013 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Oversight authority: Not applicable |
| Study type | Observational |
This study is conducted in a cohort of low dose aspirin (ASA) users previously ascertained.
The aims of the post hoc analyses are:
To estimate the incidence of uncomplicated peptic ulcer (UPU) in a cohort of low-dose ASA
for secondary prevention of vascular disease and the relative risk of UPU associated with
use and discontinuation of use of low dose ASA.
To estimate the effect of proton pump inhibitors (PPI) on the occurrence of UPU among users
of low-dose ASA for secondary prevention of vascular disease To evaluate the effect of other
risk factors on the occurrence of UPU among users of low-dose ASA for secondary prevention
of vascular disease.
| Status | Completed |
| Enrollment | 39000 |
| Est. completion date | May 2013 |
| Est. primary completion date | May 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years to 84 Years |
| Eligibility |
Inclusion Criteria: - Patients aged 50-84 years in 2000-2007 with a first prescription of low dose ASA ( see study population description) Exclusion Criteria: - Patients aged below age 50 and 85 years and above ( see study population description) |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Spain | Research Site | Madrid |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Spain,
Cea Soriano L, Rodríguez LA. Risk of Upper Gastrointestinal Bleeding in a Cohort of New Users of Low-Dose ASA for Secondary Prevention of Cardiovascular Outcomes. Front Pharmacol. 2010 Oct 14;1:126. doi: 10.3389/fphar.2010.00126. eCollection 2010. — View Citation
García Rodríguez LA, Cea Soriano L, Hill C, Johansson S. Increased risk of stroke after discontinuation of acetylsalicylic acid: a UK primary care study. Neurology. 2011 Feb 22;76(8):740-6. doi: 10.1212/WNL.0b013e31820d62b5. Epub 2011 Jan 26. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence rates of uncomplicated peptic ulcer in a cohort of secondary prevention aspirin users | From 1 January 2000 till 30 September 2011, an expected average of 6 years. | No | |
| Primary | Risk (hazard ratio) of developing uncomplicated peptic ulcer in a cohort of secondary prevention aspirin users | From 1 Januart 2000 till 30 September 2011, an expected average of 6 years | No |