Clopidogrel for the Prevention of Exacerbations in Severe COPD

NCT06021990 | Unknown Phase 3 DMC

• 1 other identifier: 804/LRH/MTI
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 2

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is a debilitating respiratory disorder characterized by gradual and progressive airflow limitation. It has been hypothesized that clopidogrel may have a role in reducing the exacerbation of COPD by reducing thromboembolic events. Several observational studies have found that taking clopidogrel reduces the likelihood of COPD exacerbations in patients with the disease. The study being conducted will be a randomized control trial, from March 2023 to March 2024 in the department of pulmonology, LRH. The aim of the study is to determine the role of clopidogrel in reducing the frequency of exacerbation in COPD patients compared to controls. The sampling will be done by non-probability consecutive sampling and the patients will be randomly allocated in study and control groups. Both the groups will be followed at the 3rd, 6th, and 12th months of the treatment and will be compared for the outcomes.

Conditions

COPD; COPD Exacerbation Acute

Keywords

COPD; Acute exacerbation; Clopidogrel; Randomised Clinical Trial; prevention; CLOPEX; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Number of acute exacerbations of COPD

  The rate of COPD exacerbations during a 12-month period, which is characterised as a worsening of symptoms for less than 14 days needing systemic corticosteroids and/or antibiotics as treatment or admission to hospital for the symptoms, will be the main outcome indicator.

  28 days

Secondary Outcomes (4)

• The number of hospitalisations for COPD-related exacerbations

  28 days

• Change in forced expiratory volume in one second (FEV1)

  28 days

• Death

  12 months

• Quality of life as measured by the St. George's Respiratory Questionnaire (SGRQ)

  28 days

Study Arms (2)

Clopidogrel group

EXPERIMENTAL

The clopidogrel group will receive the intervention under study (clopidogrel 75mg once daily post-meal) for the study period along with the standard of care treatment as approved by the hospital based on national and international guidelines.

Drug: Clopidogrel Bisulfate 75Mg Tab

Standard of Care

NO INTERVENTION

The standard of care will receive treatment as approved by the hospital based on national and international guidelines.

Interventions

Clopidogrel Bisulfate 75Mg Tab DRUG

Severe COPD patients who meet eligibility criteria will be given Clopidogrel Bisulfate 75 mg Tablet daily, along with standard of care treatment till the completion of the study duration or any side effects that warrants stoppage of the drug

Also known as: clopidogrel, Plavix

Clopidogrel group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with severe COPD (GOLD stage III or IV based on FEV1)
• Patients with a history of at least one exacerbation in the past year.
• Patients who are able to understand and provide informed consent.
• Patients willing and able to comply with the study protocol and attend follow-up visits.
• Patients who are between the ages of 40 and 80 years.
• Either gender

You may not qualify if:

• Patients who have previously experienced serious medical issues, like a recent heart attack or stroke (within six months),
• Patients who are known to be hypersensitive to clopidogrel.
• People who have a history of gastrointestinal bleeding or any other health issue that could make them more likely to bleed.
• Women who are pregnant or nursing.
• Patients who are being treated with additional antiplatelet or anticoagulant medications.
• Patients who are being treated with clopidogrel for any other indication.
• People who suffer from severe renal or liver illness.

Sponsors & Collaborators

• Lady Reading Hospital, Pakistan: lead
• Pakistan Chest Society, Pakistan: collaborator

Study Sites (2)

Pulmonology Department, Lady Reading Hospital, Peshawar

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

RECRUITING

Saidu Teaching Hospital, Swat

Swāt, Khyber Pakhtunkhwa, 19110, Pakistan

RECRUITING

Related Publications (7)

• Pahal P, Hashmi MF, Sharma S. Chronic Obstructive Pulmonary Disease Compensatory Measures. 2023 Jun 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK525962/

  PMID: 30247837 BACKGROUND

• Murarescu ED, Mitrofan EC, Mihailovici MS. Chronic obstructive pulmonary disease in a new concept. Rom J Morphol Embryol. 2007;48(3):207-14.

  PMID: 17914487 BACKGROUND

• Kim V, Aaron SD. What is a COPD exacerbation? Current definitions, pitfalls, challenges and opportunities for improvement. Eur Respir J. 2018 Nov 15;52(5):1801261. doi: 10.1183/13993003.01261-2018. Print 2018 Nov.

  PMID: 30237306 BACKGROUND

• Beekman E, Mesters I, Hendriks EJ, Muris JW, Wesseling G, Evers SM, Asijee GM, Fastenau A, Hoffenkamp HN, Gosselink R, van Schayck OC, de Bie RA. Exacerbations in patients with chronic obstructive pulmonary disease receiving physical therapy: a cohort-nested randomised controlled trial. BMC Pulm Med. 2014 Apr 26;14:71. doi: 10.1186/1471-2466-14-71.

  PMID: 24767519 BACKGROUND

• Damman P, Woudstra P, Kuijt WJ, de Winter RJ, James SK. P2Y12 platelet inhibition in clinical practice. J Thromb Thrombolysis. 2012 Feb;33(2):143-53. doi: 10.1007/s11239-011-0667-5.

  PMID: 22183178 BACKGROUND

• Kunadian V, Chan D, Ali H, Wilkinson N, Howe N, McColl E, Thornton J, von Wilamowitz-Moellendorff A, Holstein EM, Burns G, Fisher A, Stocken D, De Soyza A; APPLE COPD-ICON2 Trial Investigators. Antiplatelet therapy in the primary prevention of cardiovascular disease in patients with chronic obstructive pulmonary disease: protocol of a randomised controlled proof-of-concept trial (APPLE COPD-ICON 2). BMJ Open. 2018 May 26;8(5):e020713. doi: 10.1136/bmjopen-2017-020713.

  PMID: 29804061 BACKGROUND

• Pavasini R, Biscaglia S, d'Ascenzo F, Del Franco A, Contoli M, Zaraket F, Guerra F, Ferrari R, Campo G. Antiplatelet Treatment Reduces All-Cause Mortality in COPD Patients: A Systematic Review and Meta-Analysis. COPD. 2016 Aug;13(4):509-14. doi: 10.3109/15412555.2015.1099620. Epub 2015 Dec 17.

  PMID: 26678708 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Zafar Iqbal, MBBS, MCPS, FCPS, DHPE

  Lady Reading Hospital, Pakistan

  STUDY CHAIR

Central Study Contacts

Muhammad Imran, MBBS, FCPS

CONTACT

+923339457550; drimransth@gmail.com

Fakhra Mushtaq, MBBS

CONTACT

+923459614046; fakhramushtaq2@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: After assessing eligibility and consent patients will be randomly assigned to either the intervention arm or control arm. The control arm would be standard of care treatment according to GOLD guidelines and approved by the Pakistan Chest Society. The intervention arm will take Clopidogrel 75mg dail according the study prototcol

Study Record Dates

• First Submitted: August 27, 2023
• First Posted: September 1, 2023
• Study Start: October 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: October 3, 2023

Record last verified: 2023-10

Locations

PA (2)