CLOPEX: Clopidogrel in Preventing Exacerbations in Severe COPD

Sponsor

Lady Reading Hospital, Pakistan (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06021990

Collaborator

Pakistan Chest Society, Pakistan (Other)

162

Enrollment

Location

Arms

Anticipated Duration (Months)

10.8

Patients Per Site Per Month

Study Details

Study Description

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 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 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 3rd, 6th and 12th month of the treatment and will be compared for the outcomes.

Condition or Disease	Intervention/Treatment	Phase
COPD COPD Exacerbation Acute	Drug: Clopidogrel Bisulfate 75Mg Tab	Phase 3

Detailed Description

Chronic Obstructive Pulmonary Disease (COPD) is a debilitating respiratory disorder characterised by gradual and progressive airflow limitation. It is a huge worldwide health issue as well as a major cause of morbidity and mortality1. Currently, it is the third leading cause of death2. Exacerbations, or abrupt worsening of symptoms that necessitate medical treatment, are common in people with severe COPD3. Exacerbations negatively influence patients' quality of life and are linked to higher healthcare utilisation and mortality4.

Clopidogrel is a widely used antiplatelet medication that works by inhibiting platelet aggregation by blocking the P2Y12 receptor5. 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 disease6. A meta-analysis on reduction of all-cause mortality in COPD patients concluded that mortality might significantly lower in COPD patients receiving antiplatelet treatment7. 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, randomised 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. To offer more firm information on the possible benefits and dangers of clopidogrel in this patient population, larger, well-designed RCTs are required. 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.

Results of the study if successful, will have two impacts. First, it will help reducing the financial burden on our health care system. Second, it will improve the quality of life of patients by less frequent hospital visits with lowered mortality.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

162 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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 prototcolAfter 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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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: clopidogrel Plavix
No Intervention: Standard of Care The standard of care will receive treatment as approved by the hospital based on national and international guidelines.

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:

clopidogrel

Plavix

No Intervention: Standard of Care

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

Outcome Measures

Primary Outcome Measures

Number of acute exacerbations of COPD [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.

Secondary Outcome Measures

The number of hospitalisations for COPD-related exacerbations [28 days]
The number of hospitalisations required for acute exacerbation of COPD will be compared in both the intervention arm and control arm.
Change in forced expiratory volume in one second (FEV1) [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
Death [12 months]
Mortality and survival will be compared between the intervention arm and the control arm till the completion of the study
Quality of life as measured by the St. George's Respiratory Questionnaire (SGRQ) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients diagnosed with severe COPD (GOLD stage III or IV)
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.
People who suffer from severe renal or liver illness.