Clopidogrel for the Prevention of Exacerbations in Severe COPD (CLOPEX)

October 2, 2023 updated by: Muhammad Imran, Lady Reading Hospital, Pakistan

Role of Clopidogrel in Preventing Exacerbations in Patients With Severe COPD: An Open-label Randomized Controlled Trial.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

162

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Khyber Pakhtunkhwa
      • Peshawar, Khyber Pakhtunkhwa, Pakistan, 25000
        • Recruiting
        • Pulmonology Department, Lady Reading Hospital, Peshawar
        • Contact:
      • Swāt, Khyber Pakhtunkhwa, Pakistan, 19110
        • Recruiting
        • Saidu Teaching Hospital, Swat
        • Contact:
          • Ajmal Khan, MBBS, FCPS
          • Phone Number: +923459589193

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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
Other Names:
  • Plavix
  • clopidogrel
No Intervention: Standard of Care
The standard of care will receive treatment as approved by the hospital based on national and international guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of acute exacerbations of COPD
Time Frame: 28 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 12 months
Mortality and survival will be compared between the intervention arm and the control arm till the completion of the study
12 months
The number of hospitalisations for COPD-related exacerbations
Time Frame: 28 days
The number of hospitalizations required for acute exacerbation of COPD will be compared in both the intervention arm and control arm.
28 days
Change in forced expiratory volume in one second (FEV1)
Time Frame: 28 days
The changes in FEV1 measured with a spirometer during the follow-up visits will be compared between the intervantion arm and the control arm till the completion of the study
28 days
Quality of life as measured by the St. George's Respiratory Questionnaire (SGRQ)
Time Frame: 28 days
Quality of life as measured by the St. George's Respiratory Questionnaire (SGRQ) will be compared between the intervention arm and the control arm till the completion of the study. Calculated results include four scores: symptoms, activity, impacts, and total. Better health is indicated by lower scores. Maximum raw scores are as follows: 662.5, 1209.1, 2117.8, and 3989.4
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lady Reading Hospital, Pakistan

Collaborators

Pakistan Chest Society, Pakistan

Investigators

  • Study Chair: Zafar Iqbal, MBBS, MCPS, FCPS, DHPE, Lady Reading Hospital, Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

August 27, 2023

First Submitted That Met QC Criteria

August 27, 2023

First Posted (Actual)

September 1, 2023

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 804/LRH/MTI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COPD

Clinical Trials on Clopidogrel Bisulfate 75Mg Tab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe