NCT01627431

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
410

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2012

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 25, 2012

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

November 28, 2012

Status Verified

November 1, 2012

Enrollment Period

2 years

First QC Date

June 14, 2012

Last Update Submit

November 27, 2012

Conditions

Peripheral Arterial Disease

Keywords

PADPeripheral revascularizationAntiplatelet therapyResidual platelet activity

Outcome Measures

Primary Outcomes (1)

  • Residual Platelet Activity

    Evaluate the high residual platelet activity prevalence in PAD patients

    2 years

Secondary Outcomes (6)

  • Target vessels thrombosis

    2 years

  • Major Cardiac Events

    2 years

  • Platelet aggregation tests

    2 years

  • Oxidative stress

    2 years

  • Laboratory tests predictive values

    2 years

  • +1 more secondary outcomes

Study Arms (1)

Antiplatelet therapy

OTHER

Patients underwent peripheral revascularization procedures undergoing a double antiplatelet therapy

Drug: Acetylsalicylic acidDrug: Clopidogrel

Interventions

Acetylsalicylic acidDRUG

100 mg once per day

Also known as: Aspirin
Antiplatelet therapy
ClopidogrelDRUG

75 mg once per day

Also known as: Plavix
Antiplatelet therapy

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Acute Limb Ischemia patients
  • Patients that underwent a peripheral revascularization procedure within 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Florence - Azienda Ospedaliero-Universitaria Careggi

Florence, Florence, 50134, Italy

NOT YET RECRUITING

Sapienza- University of Rome -Azienda Policlinico Umberto I

Rome, Rome, 00161, Italy

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

AspirinClopidogrel

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTiclopidineThienopyridinesThiophenesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Francesco Violi, MD

    Divisione di Prima Clinica Medica - Sapienza University of Rome

    STUDY CHAIR

  • Rosanna Abate, MD

    Azienda Ospedaliero-Universitaria Careggi University of Florence

    STUDY CHAIR

Central Study Contacts

Francesco Violi, Prof

CONTACT

+39-06-4461933francesco.violi@uniroma1.it

Stefania Basili, Prof

CONTACT

+39-06-49974678stefania.basili@uniroma1.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

June 14, 2012

First Posted

June 25, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2015

Last Updated

November 28, 2012

Record last verified: 2012-11

Locations

IT(2)