Assessment of Platelet Aggregability in Patients Patients with Non-small Cell Lung CarcinomaPhase 2/3NCT06872541
Evaluation of Platelet Aggregability in Patients with Non-small Cell Lung Carcinomas
A Phase 2/3 study testing Clopidogrel in people with Assessment of Platelet Aggregability in Patients Patients with Non-small Cell Lung Carcinoma, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Cancer patients are at greater risk of experiencing events thrombotic, arterial or venous, during the course of the disease. Specifically in lung cancer, patients are seven times more prone to developing venous thrombosis, when compared to general population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Assessment of Platelet Aggregability in Patients Patients with Non-small Cell Lung Carcinoma
- What is being tested?
- Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jan 2025to 20 Oct 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients > 18 years old;
- Confirmed diagnosis of non-small cell lung carcinoma in the case group; absence of history of any neoplasia for control group
- Agreement to sign the Free and Informed Consent Form
Who cannot join
- Anticoagulation in the last 30 days;
- Use of any antiplatelet agent in the last 30 days;
- Use of any non-steroidal anti-inflammatory drugs in the last 30 days;
- Known platelet dysfunction or platelets <100,000/mm3 or >450,000/mm3;
- Creatinine clearance by MDRD <30 ml/min/1.73 m2
- Eastern Cooperative Oncology Group Performance Status Scale (ECOG) >2
- Known coagulation disorder;
- Hematocrit less than 34% or greater than 55%
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Heart Institute (InCor) / University of São Paulo
São Paulo, São Paulo
About this study
Cancer patients are at greater risk of experiencing events thrombotic, arterial or venous, during the course of the disease. Specifically in lung cancer, patients are seven times more prone to developing venous thrombosis, when compared to general population. Platelets influence cancer progression and Tumor microenvironment facilitates platelet activation. Therefore, the main objective of this project is to evaluate platelet aggregation analyzed by aggregometry optics with the use of AggRAM® equipment in patients diagnosed recent non-small cell lung carcinomas, prior to any oncological treatment. Among the secondary objectives, it stands out analyze the primary objective using the PPAnalysis® method (method in developed by our group in partnership with the University of Readings (UK), Plateletworks® and Chrono-log. This is a case-control study, with groups differentiated by the presence or absence of malignant lung neoplasia and matched by age, sex and presence or absence of smoking in the previous 6 months to inclusion. Patients diagnosed with non-cell lung carcinoma Small children without prior treatment will be candidates for participation in the study.
It is expected that at the end important aspects related to aggregation platelet disease are better characterized in this neoplasm, the most important cause of death from cancer in the world, and therapeutic strategies to improvement in morbidity and mortality in the disease can be developed.
Read the detailed description
Cancer patients are at increased risk of thrombotic complications, especially venous thromboembolism (VTE). The oncology population is seven times more likely to develop thrombosis when compared to the general population, with an incidence of up to 20% of patients during follow-up. It is suggested that the reasons for this greater thrombotic risk are immobility, invasive procedures and changes in coagulation, in addition to possible disorders of platelet aggregation and endothelial function.
The literature suggests that the basic thromboembolic mechanism would be related to the production, by tumor cells, of pro-coagulant factors such as tissue factor and neoplastic pro-coagulant. PAI-1, the main inhibitor of the plasminogen activator pathway, is also produced by tumor cells. Still, tumor production of factors inhibiting the fibrinolytic system plays a role in hypercoagulability and may contribute to tumor angiogenesis. Regarding arterial thrombotic events, although there is no unanimity regarding the causal relationship between the pathologies, epidemiological data strongly suggest that this complication is more common in patients with cancer, compared to the population without the disease.
It is worth mentioning that lung cancer is the most common cause of cancer deaths in the world. It is possible that the high mortality from lung cancer is related, at least partially, to the higher incidence of thrombotic complications presented by these patients, compared to those with other types of cancer. Although VTE is one of the main causes of morbidity and mortality in cancer patients, the use of anticoagulants as primary prophylaxis is not routinely recommended.
The pathophysiological mechanisms involved in the increased risk of thromboembolic events in cancer patients, especially with lung cancer, which, as mentioned, present, in addition to the aggressiveness of the disease itself, a higher incidence of thrombotic events, are still little known. The main objective of this project is to contribute to a better understanding of the mechanisms involved in thrombotic events in the population with lung cancer, with clear therapeutic impacts.
This is a case-control study with groups differentiated by the presence or absence of NSCLC and matched by age, sex and presence or absence of smoking in the 6 months prior to inclusion. Patients diagnosed with NSCLC without prior treatment for the disease will be candidates for participation in the study.
The primary objective is to compare platelet aggregability by optical aggregometry assessed by the AggRAM® method in patients diagnosed with NSCLC, prior to any oncological treatment, in relation to a control group matched by sex, age and presence or absence of smoking in the previous 6 months. to inclusion Secondary objetives includes laboratorial test of inflammation, coagulation and subgroup analysis.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
Clopidogrel 75 mg uma vez ao dia durante 14 dias
| Study group | Role | What they receive |
|---|---|---|
| control (group 1) | Active comparator | patients without NSCLC and matched by age, sex and presence or absence of smoking in the 6 months before inclusion Receives: Drug: Clopidogrel |
| case (group 2) | Active comparator | patients with NSCLC and matched by age, sex and presence or absence of smoking in the 6 months prior to inclusion Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet Aggregation analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratories)
Compare platelet aggregation analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratórios) between both groups
Measured: 14 days
Secondary outcomes (16)
Platelet aggregability by AggRAM™ ADP after 14 days of use of Clopidogrel 75 mg/day
Evaluation of Platelet aggregability by AggRAM™ ADP after 14 days of use of Clopidogrel 75 mg/day
Measured: 14 days
Platelet aggregability by Plateletworks-ADP at baseline and after 14 days of use of Clopidogrel 75 mg/day
Evaluation of Platelet aggregability by Plateletworks-ADP at baseline and after 14 days of use of Clopidogrel 75 mg/day
Measured: 14 days
Serum levels of tissue factor
Evaluation of Serum levels of tissue factor
Measured: Baseline
Serum levels of type I plasminogen activator inhibitor (PAI 1)
Evaluation of Serum levels of type I plasminogen activator inhibitor (PAI 1)
Measured: Baseline
Serum levels of immature platelets
Evaluation of Serum levels of immature platelets
Measured: Baseline
Serum levels of ultrasensitive C-reactive protein (hs-CRP);
Avaliation of Serum levels of ultrasensitive C-reactive protein (hs-CRP)
Measured: Baseline
Serum levels of interleukin 6
Evaluation of Serum levels of interleukin 6
Measured: Baseline
Serum levels of Interleukin 1
Evaluation of interleukin 1
Measured: Baseline
Serum levels of P-Selectin
Evaluation of Serum levels of P-Selectin
Measured: Baseline
Serum levels of D-dimero
Evaluation of Serum levels of D-dimero
Measured: Baseline
Serum levels of Lipoprotein(a) (LPa)
Evaluation of Serum levels of Lipoprotein(a) (LPa)
Measured: Baseline
Serum levels of Glycated hemoglobin
Evaluation of Serum levels of Glycated hemoglobin
Measured: Baseline
Serum levels of coagulogram
Evaluation of Serum levels of coagulogram
Measured: Baseline
Serum levels of Fibrinogen
Evaluation of Serum levels of Fibrinogen
Measured: Baseline
Serum levels of cholesterol ester transfer proteins
Evaluation of Serum levels of cholesterol ester transfer proteins
Measured: Baseline
Serum levels of blood count with platelets
Evaluation of Serum levels of blood count with platelets
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start20 Jan 2025
- Primary completion20 Oct 2026 (estimated)
- Study completion20 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Assessment of Platelet Aggregability in Patients Patients with Non-small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Carlos Nicolau, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872541
- Sponsor's protocol ID
- 5788/23/190
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fuentes HE, Oramas DM, Paz LH, Casanegra AI, Mansfield AS, Tafur AJ. Meta-analysis on anticoagulation and prevention of thrombosis and mortality among patients with lung cancer. Thromb Res. 2017 Jun;154:28-34. doi: 10.1016/j.thromres.2017.03.024. Epub 2017 Apr 1.
PubMed 28402864Mutlu H, Artis TA, Erden A, Akca Z. Alteration in mean platelet volume and platicrit values in patients with cancer that developed thrombosis. Clin Appl Thromb Hemost. 2013 Jun;19(3):331-3. doi: 10.1177/1076029611433644. Epub 2012 Feb 16.
PubMed 22345488Zacharski LR, Henderson WG, Rickles FR, Forman WB, Cornell CJ Jr, Forcier RJ, Edwards RL, Headley E, Kim SH, O'Donnell JF, et al. Effect of warfarin anticoagulation on survival in carcinoma of the lung, colon, head and neck, and prostate. Final report of VA Cooperative Study #75. Cancer. 1984 May 15;53(10):2046-52. doi: 10.1002/1097-0142(19840515)53:103.0.co;2-f.
PubMed 6322957Ek L, Gezelius E, Bergman B, Bendahl PO, Anderson H, Sundberg J, Wallberg M, Falkmer U, Verma S, Belting M; Swedish Lung Cancer Study Group (SLUSG). Randomized phase III trial of low-molecular-weight heparin enoxaparin in addition to standard treatment in small-cell lung cancer: the RASTEN trial. Ann Oncol. 2018 Feb 1;29(2):398-404. doi: 10.1093/annonc/mdx716.
PubMed 29106448Macbeth F, Noble S, Evans J, Ahmed S, Cohen D, Hood K, Knoyle D, Linnane S, Longo M, Moore B, Woll PJ, Appel W, Dickson J, Ferry D, Brammer C, Griffiths G. Randomized Phase III Trial of Standard Therapy Plus Low Molecular Weight Heparin in Patients With Lung Cancer: FRAGMATIC Trial. J Clin Oncol. 2016 Feb 10;34(5):488-94. doi: 10.1200/JCO.2015.64.0268. Epub 2015 Dec 23.
PubMed 26700124Altinbas M, Coskun HS, Er O, Ozkan M, Eser B, Unal A, Cetin M, Soyuer S. A randomized clinical trial of combination chemotherapy with and without low-molecular-weight heparin in small cell lung cancer. J Thromb Haemost. 2004 Aug;2(8):1266-71. doi: 10.1111/j.1538-7836.2004.00871.x.
PubMed 15304029Meikle CK, Meisler AJ, Bird CM, Jeffries JA, Azeem N, Garg P, Crawford EL, Kelly CA, Gao TZ, Wuescher LM, Willey JC, Worth RG. Platelet-T cell aggregates in lung cancer patients: Implications for thrombosis. PLoS One. 2020 Aug 10;15(8):e0236966. doi: 10.1371/journal.pone.0236966. eCollection 2020.
PubMed 32776968Navi BB, Reiner AS, Kamel H, Iadecola C, Okin PM, Elkind MSV, Panageas KS, DeAngelis LM. Risk of Arterial Thromboembolism in Patients With Cancer. J Am Coll Cardiol. 2017 Aug 22;70(8):926-938. doi: 10.1016/j.jacc.2017.06.047.
PubMed 28818202Mangalpally KK, Siqueiros-Garcia A, Vaduganathan M, Dong JF, Kleiman NS, Guthikonda S. Platelet activation patterns in platelet size sub-populations: differential responses to aspirin in vitro. J Thromb Thrombolysis. 2010 Oct;30(3):251-62. doi: 10.1007/s11239-010-0489-x.
PubMed 20502945Heit JA, Silverstein MD, Mohr DN, Petterson TM, O'Fallon WM, Melton LJ 3rd. Risk factors for deep vein thrombosis and pulmonary embolism: a population-based case-control study. Arch Intern Med. 2000 Mar 27;160(6):809-15. doi: 10.1001/archinte.160.6.809.
PubMed 10737280Blom JW, Doggen CJ, Osanto S, Rosendaal FR. Malignancies, prothrombotic mutations, and the risk of venous thrombosis. JAMA. 2005 Feb 9;293(6):715-22. doi: 10.1001/jama.293.6.715.
PubMed 15701913Metharom P, Falasca M, Berndt MC. The History of Armand Trousseau and Cancer-Associated Thrombosis. Cancers (Basel). 2019 Jan 31;11(2):158. doi: 10.3390/cancers11020158.
PubMed 30708967Marks MA, Engels EA. Venous thromboembolism and cancer risk among elderly adults in the United States. Cancer Epidemiol Biomarkers Prev. 2014 May;23(5):774-83. doi: 10.1158/1055-9965.EPI-13-1138. Epub 2014 Mar 8.
PubMed 24608188
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Platelet Aggregability in Patients with Non-small Cell Lung Carcinomas
- ClinicalTrials.gov ID
- NCT06872541
- Acronym / sponsor ID
- 5788/23/190
- Conditions
- Assessment of Platelet Aggregability in Patients Patients with Non-small Cell Lung Carcinoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 20 Oct 2026 (estimated)
- Study completion
- 20 Oct 2027 (estimated)
- First posted
- 12 Mar 2025 (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.
Cancer patients are at greater risk of experiencing events thrombotic, arterial or venous, during the course of the disease. Specifically in lung cancer, patients are seven times more prone to developing venous thrombosis, when compared to general population. Platelets influence cancer progression and Tumor microenvironment facilitates platelet activation. Therefore, the main objective of this project is to evaluate platelet aggregation analyzed by aggregometry optics with the use of AggRAM® equipment in patients diagnosed recent non-small cell lung carcinomas, prior to any oncological treatment. Among the secondary objectives, it stands out analyze the primary objective using the PPAnalysis® method (method in developed by our group in partnership with the University of Readings (UK), Plateletworks® and Chrono-log. This is a case-control study, with groups differentiated by the presence or absence of malignant lung neoplasia and matched by age, sex and presence or absence of smoking in the previous 6 months to inclusion. Patients diagnosed with non-cell lung carcinoma Small children without prior treatment will be candidates for participation in the study.
It is expected that at the end important aspects related to aggregation platelet disease are better characterized in this neoplasm, the most important cause of death from cancer in the world, and therapeutic strategies to improvement in morbidity and mortality in the disease can be developed.
Detailed description
Cancer patients are at increased risk of thrombotic complications, especially venous thromboembolism (VTE). The oncology population is seven times more likely to develop thrombosis when compared to the general population, with an incidence of up to 20% of patients during follow-up. It is suggested that the reasons for this greater thrombotic risk are immobility, invasive procedures and changes in coagulation, in addition to possible disorders of platelet aggregation and endothelial function.
The literature suggests that the basic thromboembolic mechanism would be related to the production, by tumor cells, of pro-coagulant factors such as tissue factor and neoplastic pro-coagulant. PAI-1, the main inhibitor of the plasminogen activator pathway, is also produced by tumor cells. Still, tumor production of factors inhibiting the fibrinolytic system plays a role in hypercoagulability and may contribute to tumor angiogenesis. Regarding arterial thrombotic events, although there is no unanimity regarding the causal relationship between the pathologies, epidemiological data strongly suggest that this complication is more common in patients with cancer, compared to the population without the disease.
It is worth mentioning that lung cancer is the most common cause of cancer deaths in the world. It is possible that the high mortality from lung cancer is related, at least partially, to the higher incidence of thrombotic complications presented by these patients, compared to those with other types of cancer. Although VTE is one of the main causes of morbidity and mortality in cancer patients, the use of anticoagulants as primary prophylaxis is not routinely recommended.
The pathophysiological mechanisms involved in the increased risk of thromboembolic events in cancer patients, especially with lung cancer, which, as mentioned, present, in addition to the aggressiveness of the disease itself, a higher incidence of thrombotic events, are still little known. The main objective of this project is to contribute to a better understanding of the mechanisms involved in thrombotic events in the population with lung cancer, with clear therapeutic impacts.
This is a case-control study with groups differentiated by the presence or absence of NSCLC and matched by age, sex and presence or absence of smoking in the 6 months prior to inclusion. Patients diagnosed with NSCLC without prior treatment for the disease will be candidates for participation in the study.
The primary objective is to compare platelet aggregability by optical aggregometry assessed by the AggRAM® method in patients diagnosed with NSCLC, prior to any oncological treatment, in relation to a control group matched by sex, age and presence or absence of smoking in the previous 6 months. to inclusion Secondary objetives includes laboratorial test of inflammation, coagulation and subgroup analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control (group 1) | Active comparator | Drug: Clopidogrelpatients without NSCLC and matched by age, sex and presence or absence of smoking in the 6 months before inclusion |
| case (group 2) | Active comparator | Drug: Clopidogrelpatients with NSCLC and matched by age, sex and presence or absence of smoking in the 6 months prior to inclusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients > 18 years old;
- Confirmed diagnosis of non-small cell lung carcinoma in the case group; absence of history of any neoplasia for control group
- Agreement to sign the Free and Informed Consent Form
Key exclusion criteria (8 listed)
- Anticoagulation in the last 30 days;
- Use of any antiplatelet agent in the last 30 days;
- Use of any non-steroidal anti-inflammatory drugs in the last 30 days;
- Known platelet dysfunction or platelets <100,000/mm3 or >450,000/mm3;
- Creatinine clearance by MDRD <30 ml/min/1.73 m2
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 |
|---|---|---|
| ClopidogrelClopidogrel 75 mg uma vez ao dia durante 14 dias | Drug | case (group 2), control (group 1) |
Primary outcome
Platelet Aggregation analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratories)
Time frame: 14 days
Compare platelet aggregation analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratórios) between both groups
16 secondary outcomes
Platelet aggregability by AggRAM™ ADP after 14 days of use of Clopidogrel 75 mg/day
Time frame: 14 days
Platelet aggregability by Plateletworks-ADP at baseline and after 14 days of use of Clopidogrel 75 mg/day
Time frame: 14 days
Serum levels of tissue factor
Time frame: Baseline
Serum levels of type I plasminogen activator inhibitor (PAI 1)
Time frame: Baseline
Serum levels of immature platelets
Time frame: Baseline
Serum levels of ultrasensitive C-reactive protein (hs-CRP);
Time frame: Baseline
Serum levels of interleukin 6
Time frame: Baseline
Serum levels of Interleukin 1
Time frame: Baseline
Serum levels of P-Selectin
Time frame: Baseline
Serum levels of D-dimero
Time frame: Baseline
Serum levels of Lipoprotein(a) (LPa)
Time frame: Baseline
Serum levels of Glycated hemoglobin
Time frame: Baseline
Serum levels of coagulogram
Time frame: Baseline
Serum levels of Fibrinogen
Time frame: Baseline
Serum levels of cholesterol ester transfer proteins
Time frame: Baseline
Serum levels of blood count with platelets
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Background: PubMed 28402864Fuentes HE, Oramas DM, Paz LH, Casanegra AI, Mansfield AS, Tafur AJ. Meta-analysis on anticoagulation and prevention of thrombosis and mortality among patients with lung cancer. Thromb Res. 2017 Jun;154:28-34. doi: 10.1016/j.thromres.2017.03.024. Epub 2017 Apr 1.
- Background: PubMed 22345488Mutlu H, Artis TA, Erden A, Akca Z. Alteration in mean platelet volume and platicrit values in patients with cancer that developed thrombosis. Clin Appl Thromb Hemost. 2013 Jun;19(3):331-3. doi: 10.1177/1076029611433644. Epub 2012 Feb 16.
- Background: PubMed 6322957Zacharski LR, Henderson WG, Rickles FR, Forman WB, Cornell CJ Jr, Forcier RJ, Edwards RL, Headley E, Kim SH, O'Donnell JF, et al. Effect of warfarin anticoagulation on survival in carcinoma of the lung, colon, head and neck, and prostate. Final report of VA Cooperative Study #75. Cancer. 1984 May 15;53(10):2046-52. doi: 10.1002/1097-0142(19840515)53:103.0.co;2-f.
- Background: PubMed 29106448Ek L, Gezelius E, Bergman B, Bendahl PO, Anderson H, Sundberg J, Wallberg M, Falkmer U, Verma S, Belting M; Swedish Lung Cancer Study Group (SLUSG). Randomized phase III trial of low-molecular-weight heparin enoxaparin in addition to standard treatment in small-cell lung cancer: the RASTEN trial. Ann Oncol. 2018 Feb 1;29(2):398-404. doi: 10.1093/annonc/mdx716.
- Background: PubMed 26700124Macbeth F, Noble S, Evans J, Ahmed S, Cohen D, Hood K, Knoyle D, Linnane S, Longo M, Moore B, Woll PJ, Appel W, Dickson J, Ferry D, Brammer C, Griffiths G. Randomized Phase III Trial of Standard Therapy Plus Low Molecular Weight Heparin in Patients With Lung Cancer: FRAGMATIC Trial. J Clin Oncol. 2016 Feb 10;34(5):488-94. doi: 10.1200/JCO.2015.64.0268. Epub 2015 Dec 23.
- Background: PubMed 15304029Altinbas M, Coskun HS, Er O, Ozkan M, Eser B, Unal A, Cetin M, Soyuer S. A randomized clinical trial of combination chemotherapy with and without low-molecular-weight heparin in small cell lung cancer. J Thromb Haemost. 2004 Aug;2(8):1266-71. doi: 10.1111/j.1538-7836.2004.00871.x.
- Background: PubMed 32776968Meikle CK, Meisler AJ, Bird CM, Jeffries JA, Azeem N, Garg P, Crawford EL, Kelly CA, Gao TZ, Wuescher LM, Willey JC, Worth RG. Platelet-T cell aggregates in lung cancer patients: Implications for thrombosis. PLoS One. 2020 Aug 10;15(8):e0236966. doi: 10.1371/journal.pone.0236966. eCollection 2020.
- Background: PubMed 28818202Navi BB, Reiner AS, Kamel H, Iadecola C, Okin PM, Elkind MSV, Panageas KS, DeAngelis LM. Risk of Arterial Thromboembolism in Patients With Cancer. J Am Coll Cardiol. 2017 Aug 22;70(8):926-938. doi: 10.1016/j.jacc.2017.06.047.
- Background: PubMed 20502945Mangalpally KK, Siqueiros-Garcia A, Vaduganathan M, Dong JF, Kleiman NS, Guthikonda S. Platelet activation patterns in platelet size sub-populations: differential responses to aspirin in vitro. J Thromb Thrombolysis. 2010 Oct;30(3):251-62. doi: 10.1007/s11239-010-0489-x.
- Background: PubMed 10737280Heit JA, Silverstein MD, Mohr DN, Petterson TM, O'Fallon WM, Melton LJ 3rd. Risk factors for deep vein thrombosis and pulmonary embolism: a population-based case-control study. Arch Intern Med. 2000 Mar 27;160(6):809-15. doi: 10.1001/archinte.160.6.809.
- Background: PubMed 15701913Blom JW, Doggen CJ, Osanto S, Rosendaal FR. Malignancies, prothrombotic mutations, and the risk of venous thrombosis. JAMA. 2005 Feb 9;293(6):715-22. doi: 10.1001/jama.293.6.715.
- Background: PubMed 30708967Metharom P, Falasca M, Berndt MC. The History of Armand Trousseau and Cancer-Associated Thrombosis. Cancers (Basel). 2019 Jan 31;11(2):158. doi: 10.3390/cancers11020158.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Clopidogrel in people with Assessment of Platelet Aggregability in Patients Patients with Non-small Cell Lung Carcinoma, run by University of Sao Paulo at 1 site in Brazil.
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 3 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet Aggregation analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratories) (time frame: 14 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 NCT06872541, which also lists 13 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 12 Mar 2025.