A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease
Public ClinicalTrials.gov record NCT00501059. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00501059
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 12,546 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 55 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 5, 2007 (Actual)
- Primary completion
- Nov 15, 2016 (Actual)
- Completion
- Nov 15, 2016 (Actual)
- Last update posted
- Oct 26, 2018
2007 – 2016
United States locations
- U.S. sites
- 73
- U.S. states
- 22
- U.S. cities
- 70
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | 39294 | — |
| Not listed | Graysville | Alabama | 35073 | — |
| Not listed | Pell City | Alabama | 35125 | — |
| Not listed | Phoenix | Arizona | 85051 | — |
| Not listed | Scottsdale | Arizona | 85260 | — |
| Not listed | Tucson | Arizona | 85712 | — |
| Not listed | Hot Springs | Arkansas | 71913-4457 | — |
| Not listed | Fremont | California | 94536-3702 | — |
| Not listed | Huntington Park | California | 90255 | — |
| Not listed | Los Angeles | California | 90025 | — |
| Not listed | Rancho Cucamonga | California | 91730 | — |
| Not listed | Rolling Hills Estates | California | 90274 | — |
| Helping Hands Clinical Trials | Santa Ana | California | 92704 | — |
| Not listed | Newark | Delaware | 19702 | — |
| Medical Research Trust | Boynton Beach | Florida | 33426 | — |
| Not listed | Gainesville | Florida | 32601 | — |
| Not listed | Hialeah | Florida | 33016 | — |
| Medical Research Centers of South Florida, Inc. | Hollywood | Florida | 33021 | — |
| Office of Dr.Larry Levinson, DO | Hollywood | Florida | 33021 | — |
| Not listed | Kissimmee | Florida | 34741 | — |
| Not listed | Largo | Florida | 33770 | — |
| Not listed | Marianna | Florida | 32446-2120 | — |
| Not listed | Panama City | Florida | 32401 | — |
| Tallahassee Memorial Family | Quincy | Florida | 32351 | — |
| Not listed | Tampa | Florida | 33614 | — |
| Not listed | Atlanta | Georgia | 30318 | — |
| Not listed | Chicago | Illinois | 60628 | — |
| Not listed | Chicago | Illinois | 60631-1958 | — |
| Not listed | Lockport | Illinois | 60491 | — |
| Not listed | Vernon Hills | Illinois | 60061 | — |
| Not listed | Evansville | Indiana | 47713 | — |
| Not listed | Fort Wayne | Indiana | 46804 | — |
| Not listed | Lebanon | Kentucky | 40033 | — |
| Not listed | Prince Frederick | Maryland | 20678 | — |
| Not listed | Bridgman | Michigan | 49106 | — |
| Not listed | Cadillac | Michigan | 49601 | — |
| Not listed | Interlochen | Michigan | 49643-9264 | — |
| Not listed | Troy | Michigan | 48085 | — |
| Not listed | Port Gibson | Mississippi | 39150 | — |
| Not listed | Florissant | Missouri | 63031 | — |
| Not listed | Broken Bow | Nebraska | 68822 | — |
| Not listed | Omaha | Nebraska | 68114 | — |
| Not listed | Omaha | Nebraska | 68116-2004 | — |
| Not listed | Belvidere | New Jersey | 07823 | — |
| Not listed | Cherry Hill | New Jersey | 08084 | — |
| Not listed | Clifton | New Jersey | 07013 | — |
| Not listed | Hainesport | New Jersey | 08036 | — |
| Not listed | Jersey City | New Jersey | 07306 | — |
| Not listed | Lawrenceville | New Jersey | 08648 | — |
| Not listed | Linden | New Jersey | 07036 | — |
| PharmaTrials, Inc. | Perth Amboy | New Jersey | 08861 | — |
| Not listed | Stratford | New Jersey | 08084 | — |
| Not listed | Burlington | North Carolina | 27215 | — |
| Not listed | Columbus | North Carolina | 28722 | — |
| Not listed | Greensboro | North Carolina | 27401 | — |
| Not listed | Raleigh | North Carolina | 27609 | — |
| Not listed | Carlisle | Ohio | 45005-3320 | — |
| Not listed | Marion | Ohio | 43302 | — |
| Not listed | Montgomery | Ohio | 45242 | — |
| Not listed | Perrysburg | Ohio | 43551 | — |
| Not listed | Doylestown | Pennsylvania | 18901 | — |
| Not listed | Duncansville | Pennsylvania | 16635 | — |
| Not listed | Sellersville | Pennsylvania | 18960 | — |
| Not listed | Taylors | South Carolina | 29687 | — |
| Not listed | Daingerfield | Texas | 75638 | — |
| Not listed | McKinney | Texas | 75069 | — |
| Not listed | Rockwall | Texas | 75032 | — |
| Not listed | San Antonio | Texas | 78205-1116 | — |
| Not listed | San Marcos | Texas | 78666 | — |
| Not listed | Stephenville | Texas | 76401 | — |
| Not listed | Sugar Land | Texas | 77478 | — |
| Not listed | Honaker | Virginia | 24260 | — |
| Merit Medical Group, Inc. | Richlands | Virginia | 24641-2067 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 393 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00501059, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 26, 2018 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00501059 live on ClinicalTrials.gov.