NCT06454045Active, not recruiting
Evaluation of Platelet Aggregability in Patients With Previous Acute Myocardial Infarction or Concomitant Lower Extremity Peripheral Artery Disease
Source: ClinicalTrials.gov · Last updated 12 Jun 2024
Brief summary (registry, in English)
After an episode of acute ischemic syndrome, patients with concomitant peripheral arterial disease have a worse short- and long-term prognosis compared to patients with isolated coronary disease, but the mechanisms responsible are poorly understood. In this population, the presence of high platelet aggregability despite the use of antiplatelet drugs is related to a greater risk of future complications, including heart attack and death from all causes. Thus, the main objective of the present project is to evaluate the role of platelet aggregability, analyzed by optical aggregometry using the AggRAM® equipment, in patients with a history of previous acute myocardial infarction with and without the presence of peripheral arterial disease. Among the secondary objectives, it is worth analyzing platelet aggregability, in both groups, using the Plateletworks® method. This is a case-control study, with groups differentiated by the presence or absence of peripheral arterial disease, matched by sex and age. It is expected that, in the end, relevant aspects related to platelet aggregation will be better characterized in this high cardiovascular risk population, with a likely impact on new therapeutic strategies that can positively influence the morbidity and mortality of these patients.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 15 May 2024
- Start date
- 13 May 2024
- Primary completion date
- 13 May 2026
- Lead sponsor
- University of Sao Paulo
- Diseases
- Coronary artery disease
- NCT number
- NCT06454045
What you commit to
- Study type: Observational
- Planned participants: 100
- From 13 May 2024 to the primary completion date, 13 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of adenosine-diphosphate (ADP) receptor antagonists in the last 7 days before inclusion in the study;
- Use of Anticoagulants in the last 30 days before inclusion in the study;
Other illness
- Clopidogrel allergy;
- Known atherosclerotic carotid disease or carotid bruit;
- History of upper gastrointestinal bleeding in the last 12 months;
- Known liver disease or coagulation disorder;
Lab values
- Known platelet dysfunction or platelet count \<100,000/µL or \>450,000/µL;
Other
- Pregnancy or lactation;
- Hematocrit less than 34% or greater than 55%
Who the study is looking for
- Men and women aged ≥ 18 years;
- Daily use of AAS 81-100 mg and statins;
- History of acute myocardial infarction, proven by medical record analysis;
- Group 2 (patients with PAD): Ankle-Brachial Index number (ABI) ≤ 0.9 in at least one of the lower limbs. In diabetic patients with ABI \> 1.4, the Hallux-Brachialis Index should be performed if possible; if the patient presents a value \< 0.7, they can be included;
- Signing of the Free and Informed Consent Form.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Heart Institute (InCor) / University of São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.