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Coronary Artery DiseaseNCT06454045

Evaluation of Platelet Aggregability in Patients With Previous Acute Myocardial Infarction or Concomitant Lower Extremity Peripheral Artery Disease

An observational study of Coronary Artery Disease and Peripheral Arterial Disease, run by University of Sao Paulo at 1 site in Brazil.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Clopidogrel
How many people
100 participants
Where
1 siteBrazil
Study dates
13 May 2024to 13 May 2028
How long will I take part?
2 Weeks
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Group 1: Patients with previous infarction and isolated coronary involvement Group 2: Patients with previous AMI and concomitant presence of Lower Extremity Peripheral Artery Disease.

Who may be able to join

  • 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.

Who cannot join

  • 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;
  • Clopidogrel allergy;
  • Known atherosclerotic carotid disease or carotid bruit;
  • History of upper gastrointestinal bleeding in the last 12 months;
  • Pregnancy or lactation;
Show all 9Show fewer
  • Known platelet dysfunction or platelet count <100,000/µL or >450,000/µL;
  • Known liver disease or coagulation disorder;
  • Hematocrit less than 34% or greater than 55%

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Heart Institute (InCor) / University of São Paulo

    São Paulo, São Paulo, 05403000

Other trials in Brazil

About this study

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.

Read the detailed description

Polyvascular involvement is frequently present in atherosclerotic disease (AD). Lower Extremity Peripheral Artery Disease (PAD) represents one of the manifestations of AD; it is estimated that around 47% of people with atherosclerotic disease have involvement in more than one vascular bed, with coronary atherosclerotic disease and lower limb AD being the most prevalent.

Initial studies suggest that platelet aggregability is increased in patients with PAD and the level of platelet aggregability is associated with the severity of PAD.However, to our knowledge, there are no studies in the literature analyzing platelet aggregability in patients with previous AMI with and without the concomitant presence of PAD, which is the proposal of this research project.

This study is an observational, case-control study, matched by sex and age. Two groups will be selected: Patients with previous infarction and isolated coronary involvement (Group 1); Patients with previous AMI and concomitant presence of PAD of the lower limbs (Group 2).

Primary objective is compare platelet aggregability analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratories) between the groups. Secondary objetives includes laboratorial test of inflammation, coagulation and subgroup analysis.

Being tested
Clopidogrel
Keywords
Platelets, optical aggregometry, Lower Limb disease
Medical subject headings
Coronary Artery Disease, Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ClopidogrelDrug

    Clopidogrel 75 mg once a day for 14 days.

Study groups in NCT06454045
Study groupRoleWhat they receive
Isolated coronary involvement (Group 1)Patients with previous infarction and isolated coronary involvement
Receives: Drug: Clopidogrel
Concomitant presence of Lower Extremity Peripheral Artery Disease (Group 2)Patients with previous AMI and concomitant presence of Lower Extremity Peripheral Artery Disease
Receives: Drug: Clopidogrel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Aggregability analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratories)

    Compare platelet aggregability analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratórios) between both groups

    Measured: 14 days

Secondary outcomes (13)

  1. Platelet aggregability by AggRAM™ arachidonic acid at baseline;

    Avaliation of Platelet aggregability by AggRAM™ arachidonic acid at baseline;

    Measured: Baseline

  2. Platelet aggregability by AggRAM™ ADP after 14 days of use of Clopidogrel 75 mg/day;

    Evaluation of Platelet aggregability by AggRAM™ ADP after 14 days of use of Clopidogrel 75 mg/day;

    Measured: 14 days

  3. Platelet aggregability by Plateletworks-ADP at baseline and after 14 days of use of Clopidogrel 75 mg/day;

    Evaluation of Platelet aggregability by Plateletworks-ADP at baseline and after 14 days of use of Clopidogrel 75 mg/day;

    Measured: 14 days

  4. Serum levels of ultrasensitive C-reactive protein (hs-CRP);

    Avaliation of Serum levels of ultrasensitive C-reactive protein (hs-CRP)

    Measured: Baseline

  5. Serum levels of immature platelets;

    Evaluation of Serum levels of immature platelets;

    Measured: Baseline

  6. Platelet count;

    Evaluation of Platelet count;

    Measured: Baseline

  7. Mean platelet volume (MPV);

    Evaluation of Mean platelet volume (MPV);

    Measured: Baseline

  8. Serum levels of P-Selectin ;

    Evaluation of Serum levels of P-Selectin ;

    Measured: Baseline

  9. Serum levels of type I plasminogen activator inhibitor (PAI 1);

    Evaluation of Serum levels of type I plasminogen activator inhibitor (PAI 1);

    Measured: Baseline

  10. Serum levels of interleukin 6;

    Evaluation of Serum levels of interleukin 6;

    Measured: Baseline

  11. Serum levels of Interleukin 1

    Evaluation of Serum levels of Interleukin 1

    Measured: Baseline

  12. Serum levels of cholesterol ester transfer proteins;

    Evaluation of Serum levels of cholesterol ester transfer proteins;

    Measured: Baseline

  13. Serum levels of Lipoprotein(a) (LPa)

    Evaluation of Serum levels of Lipoprotein(a) (LPa)

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2024
  2. Study start13 May 2024
  3. Primary completion13 May 2026 (estimated)
  4. Study completion13 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
100 participants (estimated)
Target duration
2 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT06454045
Sponsor's protocol ID
SDC: 5794/24/005
Status last verified
Jun 2024
First submitted
15 May 2024
Last updated
12 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Perez Mejias EL, Faxas SM, Taveras NT, Talpur AS, Kumar J, Khalid M, Aruwani SK, Khalid D, Khalid H, Memon S. Peripheral Artery Disease as a Risk Factor for Myocardial Infarction. Cureus. 2021 Jun 15;13(6):e15655. doi: 10.7759/cureus.15655. eCollection 2021 Jun.

    PubMed 34277248

  • Hirsch AT, Criqui MH, Treat-Jacobson D, Regensteiner JG, Creager MA, Olin JW, Krook SH, Hunninghake DB, Comerota AJ, Walsh ME, McDermott MM, Hiatt WR. Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA. 2001 Sep 19;286(11):1317-24. doi: 10.1001/jama.286.11.1317.

    PubMed 11560536

  • Bauersachs R, Zeymer U, Briere JB, Marre C, Bowrin K, Huelsebeck M. Burden of Coronary Artery Disease and Peripheral Artery Disease: A Literature Review. Cardiovasc Ther. 2019 Nov 26;2019:8295054. doi: 10.1155/2019/8295054. eCollection 2019.

    PubMed 32099582

  • Fox KA, Carruthers KF, Dunbar DR, Graham C, Manning JR, De Raedt H, Buysschaert I, Lambrechts D, Van de Werf F. Underestimated and under-recognized: the late consequences of acute coronary syndrome (GRACE UK-Belgian Study). Eur Heart J. 2010 Nov;31(22):2755-64. doi: 10.1093/eurheartj/ehq326. Epub 2010 Aug 30.

    PubMed 20805110

  • Nicolau JC, Bhatt DL, Roe MT, Lokhnygina Y, Neely B, Corbalan R, Leiva-Pons JL, Martinez F, Goodman SG, Winters KJ, Verheugt FW, Armstrong PW, White HD, Fox KA, Prabhakaran D, Ohman EM; TRILOGY ACS investigators. Concomitant proton-pump inhibitor use, platelet activity, and clinical outcomes in patients with acute coronary syndromes treated with prasugrel versus clopidogrel and managed without revascularization: insights from the Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes trial. Am Heart J. 2015 Oct;170(4):683-694.e3. doi: 10.1016/j.ahj.2015.05.017. Epub 2015 Jun 11.

    PubMed 26386792

  • Nicolau JC, Feitosa Filho GS, Petriz JL, Furtado RHM, Precoma DB, Lemke W, Lopes RD, Timerman A, Marin Neto JA, Bezerra Neto L, Gomes BFO, Santos ECL, Piegas LS, Soeiro AM, Negri AJA, Franci A, Markman Filho B, Baccaro BM, Montenegro CEL, Rochitte CE, Barbosa CJDG, Virgens CMBD, Stefanini E, Manenti ERF, Lima FG, Monteiro Junior FDC, Correa Filho H, Pena HPM, Pinto IMF, Falcao JLAA, Sena JP, Peixoto JM, Souza JA, Silva LSD, Maia LN, Ohe LN, Baracioli LM, Dallan LAO, Dallan LAP, Mattos LAPE, Bodanese LC, Ritt LEF, Canesin MF, Rivas MBDS, Franken M, Magalhaes MJG, Oliveira Junior MT, Filgueiras Filho NM, Dutra OP, Coelho OR, Leaes PE, Rossi PRF, Soares PR, Lemos Neto PA, Farsky PS, Cavalcanti RRC, Alves RJ, Kalil RAK, Esporcatte R, Marino RL, Giraldez RRCV, Meneghelo RS, Lima RSL, Ramos RF, Falcao SNDRS, Dalcoquio TF, Lemke VMG, Chalela WA, Mathias Junior W. Brazilian Society of Cardiology Guidelines on Unstable Angina and Acute Myocardial Infarction without ST-Segment Elevation - 2021. Arq Bras Cardiol. 2021 Jul;117(1):181-264. doi: 10.36660/abc.20210180. No abstract available. English, Portuguese.

    PubMed 34320090

  • Smolina K, Wright FL, Rayner M, Goldacre MJ. Long-term survival and recurrence after acute myocardial infarction in England, 2004 to 2010. Circ Cardiovasc Qual Outcomes. 2012 Jul 1;5(4):532-40. doi: 10.1161/CIRCOUTCOMES.111.964700. Epub 2012 Jun 26.

    PubMed 22740013

  • Steen DL, Khan I, Andrade K, Koumas A, Giugliano RP. Event Rates and Risk Factors for Recurrent Cardiovascular Events and Mortality in a Contemporary Post Acute Coronary Syndrome Population Representing 239 234 Patients During 2005 to 2018 in the United States. J Am Heart Assoc. 2022 May 3;11(9):e022198. doi: 10.1161/JAHA.121.022198. Epub 2022 Apr 27.

    PubMed 35475346

  • Nakatani D, Sakata Y, Suna S, Usami M, Matsumoto S, Shimizu M, Sumitsuji S, Kawano S, Ueda Y, Hamasaki T, Sato H, Nanto S, Hori M, Komuro I; Osaka Acute Coronary Insufficiency Study (OACIS) Investigators. Incidence, predictors, and subsequent mortality risk of recurrent myocardial infarction in patients following discharge for acute myocardial infarction. Circ J. 2013;77(2):439-46. doi: 10.1253/circj.cj-11-1059. Epub 2012 Oct 17.

    PubMed 23075765

  • Thune JJ, Signorovitch JE, Kober L, McMurray JJ, Swedberg K, Rouleau J, Maggioni A, Velazquez E, Califf R, Pfeffer MA, Solomon SD. Predictors and prognostic impact of recurrent myocardial infarction in patients with left ventricular dysfunction, heart failure, or both following a first myocardial infarction. Eur J Heart Fail. 2011 Feb;13(2):148-53. doi: 10.1093/eurjhf/hfq194. Epub 2010 Oct 29.

    PubMed 21037250

  • Attar R, Wester A, Koul S, Eggert S, Andell P. Peripheral artery disease and outcomes in patients with acute myocardial infarction. Open Heart. 2019 May 12;6(1):e001004. doi: 10.1136/openhrt-2018-001004. eCollection 2019.

    PubMed 31245013

  • Patel MR, Becker RC, Wojdyla DM, Emanuelsson H, Hiatt WR, Horrow J, Husted S, Mahaffey KW, Steg PG, Storey RF, Wallentin L, James SK. Cardiovascular events in acute coronary syndrome patients with peripheral arterial disease treated with ticagrelor compared with clopidogrel: Data from the PLATO Trial. Eur J Prev Cardiol. 2015 Jun;22(6):734-42. doi: 10.1177/2047487314533215. Epub 2014 May 15.

    PubMed 24830710

  • Akahori H, Masuyama T, Imanaka T, Nakao K, Ozaki Y, Kimura K, Ako J, Noguchi T, Suwa S, Fujimoto K, Nakama Y, Morita T, Shimizu W, Saito Y, Hirohata A, Morita Y, Inoue T, Okamura A, Mano T, Hirata K, Tanabe K, Shibata Y, Owa M, Tsujita K, Funayama H, Kokubu N, Kozuma K, Uemura S, Tobaru T, Saku K, Oshima S, Nishimura K, Miyamoto Y, Ogawa H, Ishihara M; J-MINUET investigators. Impact of peripheral artery disease on prognosis after myocardial infarction: The J-MINUET study. J Cardiol. 2020 Oct;76(4):402-406. doi: 10.1016/j.jjcc.2020.05.014. Epub 2020 Jun 9.

    PubMed 32532585

  • Andersen P, Kragholm K, Torp-Pedersen C, Jensen SE, Attar R. The impact of peripheral artery disease on major adverse cardiovascular events following myocardial infarction. Int J Cardiol. 2021 Nov 15;343:131-137. doi: 10.1016/j.ijcard.2021.08.053. Epub 2021 Sep 6.

    PubMed 34499974

  • Breet NJ, van Werkum JW, Bouman HJ, Kelder JC, Ruven HJ, Bal ET, Deneer VH, Harmsze AM, van der Heyden JA, Rensing BJ, Suttorp MJ, Hackeng CM, ten Berg JM. Comparison of platelet function tests in predicting clinical outcome in patients undergoing coronary stent implantation. JAMA. 2010 Feb 24;303(8):754-62. doi: 10.1001/jama.2010.181.

    PubMed 20179285

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Peripheral Arterial Disease, run by University of Sao Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aggregability analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratories) (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06454045, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.

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