Clopidogrel for the Prevention of Exacerbations in Severe COPD

NCT ID: NCT06021990

Last Updated: 2023-10-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-12-31

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.

Detailed Description

Chronic Obstructive Pulmonary Disease (COPD) is a debilitating respiratory disorder characterized by gradual and progressive airflow limitation. It is a huge worldwide health issue as well as a major cause of morbidity and mortality. Currently, it is the third leading cause of death. Exacerbations, or abrupt worsening of symptoms that necessitate medical treatment, are common in people with severe COPD. Exacerbations negatively influence patients' quality of life and are linked to higher healthcare utilization and mortality.

Clopidogrel is a widely used antiplatelet medication that works by inhibiting platelet aggregation by blocking the P2Y12 receptor. Clopidogrel's potential benefits in the treatment of COPD have piqued the curiosity of researchers in recent years. According to the hypothesis, Clopidogrel may lower the incidence of exacerbations by reducing thromboembolic events, which are prevalent causes of exacerbations in COPD.

Several observational studies have found that taking clopidogrel reduces the likelihood of COPD exacerbations in patients with the disease. A meta-analysis on the reduction of all-cause mortality in COPD patients concluded that mortality might be significantly lower in COPD patients receiving antiplatelet treatment. However, because of confounding considerations, the findings of these observational studies should be regarded with caution. To confirm the potential benefits of clopidogrel in lowering COPD exacerbations, randomized controlled studies (RCTs) are required. Only a few RCTs have been undertaken to date, with inconsistent outcomes.

The inconsistent findings of the RCTs show the need for additional studies to determine the role of clopidogrel in reducing COPD exacerbations. Larger, well-designed RCTs are required to offer more firm information on the possible benefits and dangers of clopidogrel in this patient population. The RCTs should also consider clopidogrel's potential side effects, such as bleeding, which may be especially concerning in COPD patients who are frequently on numerous drugs and may have comorbidities such as cardiovascular disease.

Finally, the role of clopidogrel in lowering exacerbations in patients with severe COPD remains unknown. Observational studies suggest that clopidogrel may have some benefits, while RCT results are mixed. More research is needed to determine clopidogrel's safety and efficacy in this patient population.

The results of the study if successful, will have two impacts. First, it will help reduce the financial burden on our healthcare system. Second, it will improve patients' quality of life by less frequent hospital visits with lowered mortality.

Conditions

COPD; COPD Exacerbation Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clopidogrel group

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.

Group Type: EXPERIMENTAL

Clopidogrel Bisulfate 75Mg Tab

Intervention Type: 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

Standard of Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Clopidogrel Bisulfate 75Mg Tab

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

Intervention Type: DRUG

Other Intervention Names

clopidogrel; Plavix

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pakistan Chest Society, Pakistan

UNKNOWN

Sponsor Role: collaborator

Lady Reading Hospital, Pakistan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Muhammad Imran

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zafar Iqbal, MBBS, MCPS, FCPS, DHPE

Role: STUDY_CHAIR

Lady Reading Hospital, Pakistan

Locations

Pulmonology Department, Lady Reading Hospital, Peshawar

Peshawar, Khyber Pakhtunkhwa, Pakistan

Site Status: RECRUITING

Saidu Teaching Hospital, Swat

Swāt, Khyber Pakhtunkhwa, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Muhammad Imran, MBBS, FCPS

Role: CONTACT

drimransth@gmail.com

+923339457550

Fakhra Mushtaq, MBBS

Role: CONTACT

fakhramushtaq2@gmail.com

+923459614046

Facility Contacts

Muhammad Imran, FCPS

Role: primary

m.imran@lrh.edu.pk

03339457550

Ajmal Khan, MBBS, FCPS

Role: primary

+923459589193

References

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/

Reference Type: BACKGROUND

PMID: 30247837 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 17914487 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30237306 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 24767519 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22183178 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29804061 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26678708 (View on PubMed)

Other Identifiers

804/LRH/MTI

Identifier Type: -

Identifier Source: org_study_id