Moderate Risk of CVD Clinical Trial
— ARRIVEOfficial title:
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group Study to Assess the Efficacy (Reduction of Cardiovascular Disease Events) and Safety of 100 mg Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease
| Verified date | September 2018 |
| Source | Bayer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The use of acetylsalicylic acid in the primary prevention of cardiovascular events has been extensively studied but to a lesser extent in patients with moderate levels of cardiovascular risk. The current study is designed to prove the efficacy and tolerability of 100 mg enteric-coated Aspirin versus placebo in the prevention of cardiovascular disease (CVD) events, which include fatal and nonfatal myocardial infarction, fatal and nonfatal stroke and CV death, in a population with no history of known CVD who are at moderate risk of major CHD events (approximately 10-20% 10 year CHD risk). This corresponds to a patient population mean 10-year CVD risk of approximately 30%. Subjects are treated in a standard care setting and may receive treatment for the underlying risk factors as defined by the treating physician. Outcome events will be adjudicated by an Endpoint Adjudication Committee and the study will be monitored by an independent Data Safety Monitoring Board.
| Status | Completed |
| Enrollment | 12546 |
| Est. completion date | November 15, 2016 |
| Est. primary completion date | November 15, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 55 Years and older |
| Eligibility |
Inclusion Criteria: - Males aged 55 years and above with 2 to 4 risk factors. Male Risk Factors: - Elevated cholesterol (Tchol>200 mg/dL or LDL>130 mg/dL; as measured at screening) irrespective of current treatment - Current smoking: defined as any cigarette smoking in the past 12 months - Low HDL cholesterol (HDL<40 mg/dL; as measured at screening) - Elevated blood pressure (SBP>140 mmHg; as measured at screening) - Currently on any medication to treat high blood pressure - Positive family history of early CHD (a first-degree relative [father, mother, brother, sister, son, daughter] suffered a heart attack [myocardial infarction] before the age of 60 years) - Females aged 60 and above with 3 or more risk factors. Female Risk Factors: - Elevated cholesterol (Tchol>240 mg/dL or LDL>160 mg/dL; as measured at screening) irrespective of current treatment - Current smoking: defined as any cigarette smoking in the past 12 months - Low HDL cholesterol (HDL<40 mg/dL; as measured at screening) - Elevated blood pressure (SBP>140 mmHg; as measured at screening) - Currently on any medication to treat high blood pressure - Positive family history of early CHD (a first-degree relative [father, mother, brother, sister, son, daughter] suffered a heart attack [myocardial infarction] before the age of 60 years) - An understanding and willingness to comply with trial procedures and has given written informed consent to participate in the trial Exclusion Criteria: - History of a documented vascular event, such as MI, stroke, coronary artery angioplasty or stenting, coronary artery bypass graft, relevant arrhythmias, or congestive heart failure or vascular intervention - Patients who are at higher than moderate risk on the basis of their diabetes status, other factors known to the investigator, or the currently used national risk score - Known contraindications to the study drug, e.g. hypersensitivity to acetylsalicylic acid - Recent (in the past year) history of gastrointestinal or genitourinary bleeding or other bleeding disorders - Active diagnosed and documented reflux esophagitis - Patients presenting with any medical condition, or psychiatric or substance abuse disorder, that, in the opinion of the investigator, is likely to affect the patient's ability to complete the study or precludes the patient's participation in the study - Lactating women or women of childbearing potential - Severe liver disease or damage based on the clinical judgment of the investigator - Severe renal disease or damage based on the clinical judgement of the investigator - A definite indication for acetylsalicylic acid therapy, other antiplatelet drug, or anticoagulant in the opinion of the physician - A history of asthma induced by administration of salicylates or substances with a similar action, notably NSAIDS - Chronic, frequent (> 5 days/month) use of NSAIDs (including aspirin, or aspirin containing products), COX-2 inhibitors or metamizole - Current participation in any other trials involving investigational products within 30 days prior to the Screening Visit - Current use of an anticoagulant medication - Sitting systolic blood pressure greater than 170 mmHg |
| Country | Name | City | State |
|---|---|---|---|
| United States | Medical Research Trust | Boynton Beach | Florida |
| United States | Medical Research Centers of South Florida, Inc. | Hollywood | Florida |
| United States | Office of Dr.Larry Levinson, DO | Hollywood | Florida |
| United States | PharmaTrials, Inc. | Perth Amboy | New Jersey |
| United States | Tallahassee Memorial Family | Quincy | Florida |
| United States | Merit Medical Group, Inc. | Richlands | Virginia |
| United States | Helping Hands Clinical Trials | Santa Ana | California |
| Lead Sponsor | Collaborator |
|---|---|
| Bayer |
United States, Germany, Ireland, Italy, Poland, Puerto Rico, Spain, United Kingdom,
Gaziano JM, Brotons C, Coppolecchia R, Cricelli C, Darius H, Gorelick PB, Howard G, Pearson TA, Rothwell PM, Ruilope LM, Tendera M, Tognoni G; ARRIVE Executive Committee. Use of aspirin to reduce risk of initial vascular events in patients at moderate ris — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Number of Subjects With Adjudicated GI Bleeding by Severity | Until follow-up (approximate 6 years) | ||
| Other | Incidence of Composite Outcomes and Non-fatal MI | Until follow-up (approximate 6 years) | ||
| Other | Incidence of Composite Outcomes and Individual Outcomes in Per-protocol Population | *all other CV death without fatal MI and fatal stroke. | Until follow-up (approximate 6 years) | |
| Primary | Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack) | The primary efficacy endpoint was a composite outcome consisting of the first occurrence of confirmed MI, stroke, cardiovascular death, UA, TIA. The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses. | Until follow-up (approximate 6 years) | |
| Secondary | Time to the First Occurrence of the Composite Outcome of Cardiovascular Death, MI, or Stroke (Ischemic, Hemorrhagic, or Unknown) | The time to Composite outcome consisting of the first occurrence of cardiovascular death, MI, or stroke (ischemic, hemorrhagic, or unknown) was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses. | Until follow-up (approximate 6 years) | |
| Secondary | Time to the First Occurrence of the Individual Components of the Primary: Non-fatal MI, Total MI, Non-fatal Stroke, Total Stroke, Cardiovascular Death, UA and TIA | The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses. | Until follow-up (approximately 6 years) | |
| Secondary | Time to All-cause Mortality, the First Occurrence of All Cancers Excluding Non-melanoma Skin Cancer (NMSC) and the First Occurrence of Colon Cancer | The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses. | Until follow-up (approximately 6 years) | |
| Secondary | Incidence of All-cause Mortality, All Cancers Excluding Non-melanoma Skin Cancer and Colon Cancer | Until follow-up (approximately 6 years) | ||
| Secondary | Incidence of Confirmed MI, Stroke, Cardiovascular Death, UA, and TIA Separately | The percentages of subjects with the efficacy endpoints of confirmed MI, stroke, cardiovascular death, UA and TIA are reported separately. *all other CV death without fatal MI and fatal stroke | Until follow-up (approximately 6 years) |