COPDPhase 3CLOPEXNCT06021990
Clopidogrel for the Prevention of Exacerbations in Severe COPD
A Phase 3 study testing Clopidogrel Bisulfate 75Mg Tab in people with COPD and COPD Exacerbation Acute, run by Lady Reading Hospital, Pakistan at 2 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD, COPD Exacerbation Acute
- What is being tested?
- Clopidogrel Bisulfate 75Mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Oct 2023to 31 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites, 2 recruiting
- Recruiting
Pulmonology Department, Lady Reading Hospital, Peshawar
Peshawar, Khyber Pakhtunkhwa, 25000
Muhammad Imran, FCPS, 03339457550, m.imran@lrh.edu.pk
- Recruiting
Saidu Teaching Hospital, Swat
Swāt, Khyber Pakhtunkhwa, 19110
Ajmal Khan, MBBS, FCPS, +923459589193
About this study
Official title: 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.
Read the 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
- Being tested
- Clopidogrel Bisulfate 75Mg Tab
- Keywords
- COPD, Acute exacerbation, Clopidogrel, Randomised Clinical Trial, prevention, CLOPEX, Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clopidogrel Bisulfate 75Mg TabDrug
Also called clopidogrel, Plavix
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (4)
The number of hospitalisations for COPD-related exacerbations
The number of hospitalizations required for acute exacerbation of COPD will be compared in both the intervention arm and control arm.
Measured: 28 days
Change in forced expiratory volume in one second (FEV1)
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
Measured: 28 days
Death
Mortality and survival will be compared between the intervention arm and the control arm till the completion of the study
Measured: 12 months
Quality of life as measured by the St. George's Respiratory Questionnaire (SGRQ)
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start1 Oct 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 prototcol
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lady Reading Hospital, Pakistan
- Sponsor type
- Other government
- Collaborators
- Pakistan Chest Society, Pakistan
- Responsible party
- Principal investigator, Muhammad Imran, Lady Reading Hospital, Pakistan
- Investigators
- Zafar Iqbal, MBBS, MCPS, FCPS, DHPE, Study chair, Lady Reading Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021990
- Sponsor's protocol ID
- 804/LRH/MTI
- Acronym
- CLOPEX
- Status last verified
- Oct 2023
- First submitted
- 27 Aug 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pahal P, Hashmi MF, Sharma S. Chronic Obstructive Pulmonary Disease Compensatory Measures. 2023 Jun 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK525962/
PubMed 30247837Murarescu ED, Mitrofan EC, Mihailovici MS. Chronic obstructive pulmonary disease in a new concept. Rom J Morphol Embryol. 2007;48(3):207-14.
PubMed 17914487Kim 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.
PubMed 30237306Beekman 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.
PubMed 24767519Damman 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.
PubMed 22183178Kunadian 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.
PubMed 29804061Pavasini 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.
PubMed 26678708
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Clopidogrel in Preventing Exacerbations in Patients With Severe COPD: An Open-label Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06021990
- Acronym / sponsor ID
- CLOPEX / 804/LRH/MTI
- Conditions
- COPD, COPD Exacerbation Acute
- Keywords
- COPD, Acute exacerbation, Clopidogrel, Randomised Clinical Trial, prevention, CLOPEX, Chronic Obstructive Pulmonary Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Lady Reading Hospital, PakistanOther government
- Collaborators
- Pakistan Chest Society, Pakistan
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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 prototcol
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel group | Experimental | Drug: Clopidogrel Bisulfate 75Mg TabThe 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. |
| Standard of Care | No intervention | –The standard of care will receive treatment as approved by the hospital based on national and international guidelines. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clopidogrel Bisulfate 75Mg TabAlso: clopidogrel, PlavixSevere 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 | Drug | Clopidogrel group |
Primary outcome
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.
4 secondary outcomes
The number of hospitalisations for COPD-related exacerbations
Time frame: 28 days
Change in forced expiratory volume in one second (FEV1)
Time frame: 28 days
Death
Time frame: 12 months
Quality of life as measured by the St. George's Respiratory Questionnaire (SGRQ)
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Background: PubMed 30247837Pahal P, Hashmi MF, Sharma S. Chronic Obstructive Pulmonary Disease Compensatory Measures. 2023 Jun 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK525962/
- Background: PubMed 17914487Murarescu ED, Mitrofan EC, Mihailovici MS. Chronic obstructive pulmonary disease in a new concept. Rom J Morphol Embryol. 2007;48(3):207-14.
- Background: PubMed 30237306Kim 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.
- Background: PubMed 24767519Beekman 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.
- Background: PubMed 22183178Damman 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.
- Background: PubMed 29804061Kunadian 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.
- Background: PubMed 26678708Pavasini 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zafar Iqbal, MBBS, MCPS, FCPS, DHPE study chair
Lady Reading Hospital, Pakistan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clopidogrel Bisulfate 75Mg Tab in people with COPD and COPD Exacerbation Acute, run by Lady Reading Hospital, Pakistan at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Imran, MBBS, FCPS (+923339457550, drimransth@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of acute exacerbations of COPD (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06021990, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.