Residual Platelet Activity In Advanced Peripheral Artery Disease (TRAIANO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by University of Roma La Sapienza
Sponsor:
Collaborator:
University of Florence
Information provided by (Responsible Party):
Francesco Violi, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01627431
First received: June 14, 2012
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

The peripheral arterial disease (PAD) is a common atherosclerotic disease manifestation and its prevalence increase with age and with the simultaneous presence of cardiovascular risk factors.

PAD patients are usually treated, as a first line treatment, with the exercise therapy, combined with the pharmacological antiplatelet therapy.

In the case of first line therapy failure, PAD patients usually undergoing to invasive revascularization procedures.

After a peripheral stent has been located, the major follow-up problem is the restenosis rate.

Published studies describe how, in a large amount of patients, can be recognised an high residual platelet activity. These data about PAD patients at the moment are lacking .

The authors would evaluate the incidence of PAD patients with an high residual platelet activity.


Condition Intervention Phase
Peripheral Arterial Disease
Drug: Acetylsalicylic acid
Drug: Clopidogrel
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Tailored Strategy for Residual Platelet Activity In Advanced Peripheral Artery Disease: New Optimal Management.

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • Residual Platelet Activity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Evaluate the high residual platelet activity prevalence in PAD patients


Secondary Outcome Measures:
  • Target vessels thrombosis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Evaluate the target vessels thrombosis incidence

  • Major Cardiac Events [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Evaluate the Major Cardiac Events (MACE) incidence in PAD patients undergoing the peripheral revascularization procedures.

  • Platelet aggregation tests [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Compare the different platelet aggregation tests specificity, sensitivity, accuracy and predictive values

  • Oxidative stress [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Evaluate platelet activation and oxidative stress indexes relationship

  • Laboratory tests predictive values [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Evaluate the different laboratory tests (platelet aggregation, oxidative stress markers, seric thromboxane) predictive values in identify recurrent thrombosis high risk patients

  • High risk patients score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Validate a clinical-laboratoristic predictive score in order to identify recurrent thrombosis high risk patients


Estimated Enrollment: 410
Study Start Date: July 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Antiplatelet therapy
Patients underwent peripheral revascularization procedures undergoing a double antiplatelet therapy
Drug: Acetylsalicylic acid
100 mg once per day
Other Name: Aspirin
Drug: Clopidogrel
75 mg once per day
Other Name: Plavix

Detailed Description:

The peripheral arterial disease (PAD) is a common atherosclerotic disease manifestation and its prevalence increases with age and with the co-presence of cardiovascular risk factors. PAD affects a large proportion of the adult population, with an age-adjusted prevalence of 4-15% which increases to 29% in case of comorbidity such as the presence of diabetes mellitus in the same individual. Less than 20% of patients with peripheral arterial laments the typical symptom of "claudication intermittens". Studies on the symptomatic PAD natural history indicate that the risk of limb loss in non-diabetic patients is low (2% or less), but the cardiovascular disease represent the leading cause of death; the annual rate of cardiovascular events (myocardial infarction, stroke or cardiovascular death) is between 5 and 7%. Medical treatment and / or surgery in this type of patient should be directed not only to improve the walking autonomy but also to reduce cardiovascular risk. Claudicant patients first-line therapy is based on structured physical exercise program and, in some specific cases, on the antiplatelet pharmacological therapy. The lack of response to exercise and / or drug therapy should lead to the next level of decision making, which is to consider limb revascularization procedures. However, in patients with suspected proximal lesion (gluteal claudication or absent femoral pulse), revascularization procedures could be considered as a first line therapy. When the revascularization procedures are considered, the first choice intervention should be the endovascular strategy, considering the lowest number of periprocedural complications. Recommendations for optimal drug therapy after revascularisation procedures in the lower limbs are hampered by lack of agreement on the optimal role of these procedures, and lack of data from randomized clinical trials. Transluminal angioplasty (PTA), primary or associated with stenting, is recommended for focal stenotic lesions of the iliac (common and external first section) and femoral-popliteal axis, particularly when the claudication intermittents is considered as severe, rather than critical ischemia. Also, this approach is recommended in non-diabetic patients with a relatively preserved tibial vessels flow. Exists a minor agreement about endovascular procedures use in extended occlusive lesions. In recent years, has become more common the use of open or covered stents during endovascular treatments in order to make it more secure and durable over time, especially in obstructive and extended lesions. This has certainly led to improved primary patency outcomes, but has entailed and still entails additional problems of drug therapy agreement.

Nowadays, the main problem concerning lower limbs revascularization is the post-procedure anti-thrombotic pharmacological treatment and the different antiplatelet drugs effectiveness This issue was addressed in two meta-analyses, where have been shown how the data are not conclusive. Moreover, a recent study by Marcucci et al (Circulation. 2009; 119: 237-42) has clearly shown that impaired platelet activation inhibition is a crucial point for the prevention of vascular outcomes, because residual platelet reactivity has been associated with adverse vascular outcomes.

Overall, these data identify two key issues:

  1. Platelet hyperactivation, usually observed after revascularization procedures;
  2. The platelet inhibition percentage appears crucial to reduce postoperative thrombotic complications and restenosis early onset.

Therefore, a unique aspect of this study is to analyze whether after peripheral revascularization procedures a platelet hyperactivation is observed and evaluate the possible involved mechanisms. In fact, the knowledge of the underlying mechanism could lead to more appropriate pharmacological approach to prevent platelet activation. In this context, the authors would explore the role of reactive oxygen species (ROS) in inducing platelet activation in patients with PAD undergoing revascularization devices.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Claudicatio Intermittens affected patients in which both exercise than pharmacological therapies failed
  • Ankle Brachial Index < 0.9 or > 1.3
  • Peripheral Arteries stenosis > 50% bilateral

Exclusion Criteria:

  • Acute Limb Ischemia patients
  • Patients that underwent a peripheral revascularization procedure within 6 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01627431

Contacts
Contact: Francesco Violi, Prof +39-06-4461933 francesco.violi@uniroma1.it
Contact: Stefania Basili, Prof +39-06-49974678 stefania.basili@uniroma1.it

Locations
Italy
University of Florence - Azienda Ospedaliero-Universitaria Careggi Not yet recruiting
Florence, Italy, 50134
Contact: Rosanna Abbate, MD    055 7949417 ext +39    rosanna.abbate@unifi.it   
Principal Investigator: Rosanna Abbate, MD         
Sub-Investigator: Rossella Marcucci, MD         
Sapienza- University of Rome -Azienda Policlinico Umberto I Recruiting
Rome, Italy, 00161
Contact: Francesco Violi, MD    06 4461933 ext +39    francesco.violi@uniroma1.it   
Contact: Stefania Basili, MD    06 49974678 ext +39    stefania.basili@uniroma1.it   
Principal Investigator: Francesco Violi, MD         
Sub-Investigator: Stefania Basili, MD         
Sub-Investigator: Giulio Illuminati, MD         
Sub-Investigator: Bruno Gossetti, MD         
Sub-Investigator: Paolo di Marzo, MD         
Sub-Investigator: Francesco Speziale, MD         
Sub-Investigator: Antonella Marcoccia, MD         
Sponsors and Collaborators
University of Roma La Sapienza
University of Florence
Investigators
Study Chair: Francesco Violi, MD Divisione di Prima Clinica Medica - Sapienza University of Rome
Study Chair: Rosanna Abate, MD Azienda Ospedaliero-Universitaria Careggi University of Florence
  More Information

No publications provided

Responsible Party: Francesco Violi, Prof., University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01627431     History of Changes
Other Study ID Numbers: SAPIENZA-PAD
Study First Received: June 14, 2012
Last Updated: November 27, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by University of Roma La Sapienza:
PAD
Peripheral revascularization
Antiplatelet therapy
Residual platelet activity

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 20, 2014