Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To investigate the risk of major bleeding (including gastrointestinal and intracranial bleeding episodes) among new users of low-dose acetylsalicylic acid (ASA) in clinical practice
These will be based on population-based cohorts using data from a primary care database in the UK: The Health Improvement Network (THIN) and will serve to make a clinically meaningful benefit-risk assessment regarding major bleeding consequences of ASA exposure in general population.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetylsalicylic Acid | New users of low-dose Acetylsalicylic Acid (ASA) |
| |
| Other medications | Users of other medications such as clopidogrel, oral anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs) and selective serotonin reuptake inhibitors (SSRIs) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetylsalicylic Acid (Aspirin, BAYE4465) | Drug | Low-dose ASA for secondary prevention of cardiovascular events |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Intracranial bleeding among new users of low-dose Acetylsalicylic acid (ASA). | Up to 13 years | |
| Incidence of Upper gastrointestinal bleeding among new users of low-dose ASA. | Up to 13 years | |
| Incidence of Lower gastrointestinal bleeding among new users of low-dose ASA | Up to 13 years | |
| Time to Intracranial bleeding among new users of low-dose ASA | Up to 13 years | |
| Time to Upper gastrointestinal bleeding among new users of low-dose ASA | Up to 13 years | |
| Time to Lower gastrointestinal bleeding among new users of low-dose ASA | Up to 13 years | |
| Relative risk of Intracranial bleeding among new users of low dose ASA | Relative risk is calculated as incident rate ratio produced by dividing the incidence rate of the outcome of interest in the exposed category by the incidence rate of the outcome of interest in the unexposed. | Up to 13 years |
| Relative risk of Upper gastrointestinal bleeding among new users of low-dose ASA | Relative risk is calculated as incident rate ratio produced by dividing the incidence rate of the outcome of interest in the exposed category by the incidence rate of the outcome of interest in the unexposed. | Up to 13 years |
| Measure | Description | Time Frame |
|---|---|---|
| Relative risk of Intracranial bleeding associated with use of other medications. | Relative risk is calculated as incident rate ratio produced by dividing the incidence rate of the outcome of interest in the exposed category by the incidence rate of the outcome of interest in the unexposed.To estimate relative risk in users of other medications such as clopidogrel,oral anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs) and selective serotonin reuptake inhibitors (SSRIs), independently from use of low-dose ASA and concomitantly |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
THIN is a computerized medical research database that contains systematically recorded data on more than 3 million UK primary care patients. It is representative of this population with regard to age, sex, and geographic distribution, and has been validated for use in pharmacoepidemiological and epidemiological research in multiple studies 13. Participating Primary Care Physicians (PCPs) record prospectively data as part of their routine patient care, including demographics and life style factors (e.g. alcohol use, body mass index (BMI) and smoking status), consultation rates, referrals, hospital admissions, laboratory test results, diagnoses, prescriptions ordered by the PCPs, and a free text section, and send their data anonymously to THIN for use in research projects.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29093065 | Result | Cea Soriano L, Gaist D, Soriano-Gabarro M, Bromley S, Garcia Rodriguez LA. Low-dose aspirin and risk of intracranial bleeds: An observational study in UK general practice. Neurology. 2017 Nov 28;89(22):2280-2287. doi: 10.1212/WNL.0000000000004694. Epub 2017 Nov 1. | |
| 28371181 | Result | Cea Soriano L, Gaist D, Soriano-Gabarro M, Garcia Rodriguez LA. Incidence of intracranial bleeds in new users of low-dose aspirin: a cohort study using The Health Improvement Network. J Thromb Haemost. 2017 Jun;15(6):1055-1064. doi: 10.1111/jth.13686. Epub 2017 May 2. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D017202 | Myocardial Ischemia |
| D003327 | Coronary Disease |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| D000925 | Anticoagulants |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| D017367 | Selective Serotonin Reuptake Inhibitors |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
Not provided
Not provided
Not provided
Not provided
Not provided
| Clopidogrel, Oral Anticoagulants, NSAIDs and SSRIs | Drug | Secondary prevention of cardiovascular events |
|
| Relative risk of Lower gastrointestinal bleeding among new users of low-dose ASA |
Relative risk is calculated as incident rate ratio produced by dividing the incidence rate of the outcome of interest in the exposed category by the incidence rate of the outcome of interest in the unexposed. |
| Up to 13 years |
| Up to 13 years |
| Relative risk of Upper gastrointestinal bleeding associated with use of other medications | Relative risk is calculated as incident rate ratio produced by dividing the incidence rate of the outcome of interest in the exposed category by the incidence rate of the outcome of interest in the unexposed.To estimate relative risk in users of other medications such as clopidogrel,oral anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs) and selective serotonin reuptake inhibitors (SSRIs), independently from use of low-dose ASA and concomitantly | Up to 13 years |
| Relative risk of Lower gastrointestinal bleeding associated with use of other medications. | Relative risk is calculated as incident rate ratio produced by dividing the incidence rate of the outcome of interest in the exposed category by the incidence rate of the outcome of interest in the unexposed.To estimate relative risk in users of other medications such as clopidogrel,oral anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs) and selective serotonin reuptake inhibitors (SSRIs), independently from use of low-dose ASA and concomitantly | Up to 13 years |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006401 | Hematologic Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D000893 | Anti-Inflammatory Agents |
| D018501 | Antirheumatic Agents |
| D014179 | Neurotransmitter Uptake Inhibitors |
| D049990 | Membrane Transport Modulators |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D018377 | Neurotransmitter Agents |
| D018490 | Serotonin Agents |