Using clopidogrel to prevent flare-ups in severe COPD patients
Role of Clopidogrel in Preventing Exacerbations in Patients With Severe COPD: An Open-label Randomized Controlled Trial.
This study is testing if the medication clopidogrel can help people with severe COPD have fewer flare-ups over the course of a year.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 162 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Lady Reading Hospital, Pakistan Government |
| Locations | 2 sites (Peshawar, Khyber Pakhtunkhwa and 1 other locations) |
| Trial ID | NCT06021990 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of clopidogrel, an antiplatelet medication, in reducing the frequency of exacerbations in patients with severe Chronic Obstructive Pulmonary Disease (COPD). Conducted as a randomized controlled trial, participants diagnosed with severe COPD and a history of exacerbations will be randomly assigned to receive either clopidogrel or a control treatment. The study will follow participants over a year, with assessments at 3, 6, and 12 months to evaluate the outcomes related to exacerbation rates. The aim is to provide robust evidence on whether clopidogrel can significantly lower the incidence of acute exacerbations in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 40 to 80 with severe COPD who have experienced at least one exacerbation in the past year.
Not a fit: Patients with recent serious medical issues, hypersensitivity to clopidogrel, or those on other antiplatelet medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a new preventive treatment option for patients with severe COPD, potentially improving their quality of life and reducing healthcare costs associated with exacerbations.
How similar studies have performed: While observational studies suggest clopidogrel may reduce COPD exacerbations, this randomized controlled trial approach is necessary to confirm its efficacy and is considered a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Peshawar, Khyber Pakhtunkhwa and 1 other locations
- Pulmonology Department, Lady Reading Hospital, Peshawar — Peshawar, Khyber Pakhtunkhwa, Pakistan (Recruiting)
- Saidu Teaching Hospital, Swat — Swāt, Khyber Pakhtunkhwa, Pakistan (Recruiting)
Study contacts
- Study coordinator: Muhammad Imran, MBBS, FCPS
- Email: drimransth@gmail.com
- Phone: +923339457550
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.