Platelet Reactivity in PAD Undergoing Percutaneous Angioplasty

NCT04165629 | Unknown DMC

• 1 other identifier: Platelet reactivity in PAD
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

Dual antiplatelet therapy has a key role in a prevention of thrombosis of treated artery in patients undergoing percutaneous transluminal angioplasty (PTA). Weak therapeutic response and presence of residual platelet activity is related to high risk for stent thrombosis and it is well in known in coronary artery disease (CAD) patients undergoing percutaneous coronary intervention (PCI). However there are few data on the association between a different entity of platelet inhibition on antiplatelet treatment and clinical outcomes in patients with peripheral artery disease (PAD). The aim of this study was to evaluate the degree of on-treatment platelet reactivity, and its association with ischemic and hemorrhagic adverse events at follow up in PAD patients undergoing PTA.

Conditions

Peripheral Artery Disease; Critical Limb Ischemia; Claudication, Intermittent

Outcome Measures

Primary Outcomes (2)

• Major Adverse Limb Event (MALE)

  It includes major amputation, reintervention which could be surgical or repeat angioplasty. Major amputation is defined as amputation above the ankle.

  6 months

• Mortality

  All-cause mortality

  6 months

Secondary Outcomes (2)

• Major Adverse Cardio- and Cerebrovascular Events (MACCE)

  6 months

• Bleeding complications

  6 months

Study Arms (4)

Aspirin responders

On impedance aggregometry- Multiplate analyzer, if ASPI \< 600 or ASPI/TRAP \< 0.5

Drug: Aspirin 300mg and Clopidogrel 300mg

Aspirin non-responders

On impedance aggregometry- Multiplate analyzer, if ASPI \> 600 or ASPI/TRAP \> 0.5

Drug: Aspirin 300mg and Clopidogrel 300mg

Clopidogrel responders

On impedance aggregometry- Multiplate analyzer, if ADP \< 500 or ADP/TRAP \< 0.5

Drug: Aspirin 300mg and Clopidogrel 300mg

Clopidogrel non-responders

On impedance aggregometry- Multiplate analyzer, if ADP \> 500 or ADP/TRAP \> 0.5

Drug: Aspirin 300mg and Clopidogrel 300mg

Interventions

Aspirin 300mg and Clopidogrel 300mg DRUG

Aspirin 300mg and Clopidogrel 300mg on the day of the PTA

Aspirin non-responders; Aspirin responders; Clopidogrel non-responders; Clopidogrel responders

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients treated at the Clinic for Vascular and Endovascular Surgery, Clinical Center of Serbia, Belgrade due to PAD (critical limb ischemia {CLI} or intermittent claudication {IC}) with PTA with/without stenting of aorto-iliac, femoro-popliteal and crural disease between January 1st 2020 and January 1st 2022

You may qualify if:

• \- all patients treated due to PAD with PTA with/without stenting of aorto-iliac, femoro-popliteal and crural disease at the mentioned time period with critical limb ischemia (CLI) or intermittent claudication (IC)

You may not qualify if:

• younger that 18 and older than 85
• contraindications for Aspirin and Clopidogrel use
• thrombocytopenia (\<100 x 10⁹/l)
• thrombocytosis (\>450 x 10⁹/l)
• kidney insufficiency (stage 4 and 5)
• more severe anemia (Hgb \< 100 g/l)
• severe hepatic disorder
• congestive heart failure
• known hemorrhagic disorder
• known malignant disease
• previous use of drugs with known anti-thrombocyte mechanism of action (dipyridamole, NSAID)
• use oral anticoagulant therapy
• use of corticosteroids
• use of drugs that are metabolized threw CYP3A4 (like erythromycin and rifampicin)

Sponsors & Collaborators

• Clinical Centre of Serbia: lead

Study Sites (1)

Clinical Center of Serbia

Belgrade, 11000, Serbia

RECRUITING

Related Publications (5)

• Spiliopoulos S, Pastromas G, Katsanos K, Kitrou P, Karnabatidis D, Siablis D. Platelet responsiveness to clopidogrel treatment after peripheral endovascular procedures: the PRECLOP study: clinical impact and optimal cutoff value of on-treatment high platelet reactivity. J Am Coll Cardiol. 2013 Jun 18;61(24):2428-2434. doi: 10.1016/j.jacc.2013.03.036. Epub 2013 Apr 16.

  PMID: 23602777 BACKGROUND

• Grifoni E, Gori AM, Giusti B, Valenti R, Migliorini A, Basili S, Paniccia R, Elmahdy MF, Pulli R, Pratesi C, Antoniucci D, Violi F, Marcucci R. On-Treatment Platelet Reactivity is a Predictor of Adverse Events in Peripheral Artery Disease Patients Undergoing Percutaneous Angioplasty. Eur J Vasc Endovasc Surg. 2018 Oct;56(4):545-552. doi: 10.1016/j.ejvs.2018.06.032. Epub 2018 Jul 17.

  PMID: 30025662 BACKGROUND

• Leunissen TC, Peeters Weem SM, Urbanus RT, den Ruijter HM, Moll FL, Asselbergs FW, de Borst GJ. High On-Treatment Platelet Reactivity in Peripheral Arterial Disease: A Pilot Study to Find the Optimal Test and Cut Off Values. Eur J Vasc Endovasc Surg. 2016 Aug;52(2):198-204. doi: 10.1016/j.ejvs.2016.04.019. Epub 2016 May 25.

  PMID: 27236738 BACKGROUND

• Pastromas G, Spiliopoulos S, Katsanos K, Diamantopoulos A, Kitrou P, Karnabatidis D, Siablis D. Clopidogrel responsiveness in patients undergoing peripheral angioplasty. Cardiovasc Intervent Radiol. 2013 Dec;36(6):1493-1499. doi: 10.1007/s00270-013-0577-3. Epub 2013 Feb 14.

  PMID: 23408060 BACKGROUND

• Spiliopoulos S, Pastromas G. Current status of high on-treatment platelet reactivity in patients with coronary or peripheral arterial disease: Mechanisms, evaluation and clinical implications. World J Cardiol. 2015 Dec 26;7(12):912-21. doi: 10.4330/wjc.v7.i12.912.

  PMID: 26730297 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia; Intermittent Claudication

Interventions

Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Petar Zlatanovic, MD

  Clinical Center of Serbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Petar Zlatanovic, MD

CONTACT

+381644961020; petar91goldy@gmail.com

Igor Koncar, MD PhD

CONTACT

+381668300290; dr.koncar@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 18, 2019
• Study Start: January 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: July 1, 2022
• Last Updated: July 15, 2020

Record last verified: 2020-07

Locations

SE (1)