Peripheral Arterial Disease (PAD)NCT07613840
Personalizing Thromboprophylaxis for Patients With Peripheral Artery Disease
A study testing Aspirin, Clopidogrel and Ticagrelor in people with Peripheral Arterial Disease (PAD) and Amputation, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The goal of this clinical trial is to determine whether a personalised blood clot prevention plan is more effective than standard treatment in adults with peripheral artery disease (PAD) who have undergone a procedure to restore blood flow to their legs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease (PAD), Amputation, Thrombosis
- What is being tested?
- Aspirin, Clopidogrel and Ticagrelor
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 484 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Apr 2025to 30 Jun 2027
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a named arterial extremity injury or named vessel revascularization for atherosclerosis requiring open and/or closed revascularization.
- Patients at the age of 18 or older
Who cannot join
- Patients who are younger than 18 years old
- Known pregnancy (females of childbearing potential will have a pregnancy test prior to surgery as per standard of care)
- Prisoners, defined as those who have been directly admitted from a correctional facility.
- No atherosclerosis
- Subject has active stomach ulcers
- Subject has severe hepatic impairment
- Subject has a recent history of intracranial hemorrhage. If the patient has a history of cerebral hemorrhage with no new central nervous system disease of >1 year, the study team will consult with the
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Anahita Dua, MBCHB, MBA, MSC, +12625658247, adua1@mgh.harvard.edu
Swechha Bhatt, MBBS, 339-242-0052, sbhatt12@mgh.harvard.edu
- Recruiting
Salem Hospital (Mass General Brigham)
Salem, Massachusetts, 01970
Shaidah Deghan, MD, MSC, 781-779-9219, sdeghan@mgh.harvard.edu
About this study
Official title: Personalizing Post Surgical Thromboprophylaxis for Patients With Peripheral Artery Disease
The goal of this clinical trial is to determine whether a personalised blood clot prevention plan is more effective than standard treatment in adults with peripheral artery disease (PAD) who have undergone a procedure to restore blood flow to their legs.
The main questions it aims to answer are:
Read more
- Does the personalized plan lower the rate of blood clots in the treated leg one year after the procedure?
- Does the personalized plan lower rates of amputation, repeat procedures, bleeding, and death compared to standard treatment?
Researchers will compare the personalized TARGET plan which uses a blood test to tailor each person's blood clot prevention medication to the standard treatment to see if the personalized approach works better.
Participants will:
- Be randomly assigned to either the personalized TARGET plan or standard treatment after their procedure
- Have blood tests at 1 week and at 1, 3, 6, 9, and 12 months after their procedure
- Have medications adjusted based on blood test results if assigned to the TARGET group
Read the detailed description
SCIENTIFIC RATIONALE Graft and stent thrombosis occurs in approximately 17% of PAD patients within 6 months of lower extremity revascularization and is the leading driver of amputation and death in this population. Current standard-of-care (SOC) thromboprophylaxis applies a uniform antiplatelet regimen despite well-documented inter-patient variability in platelet reactivity and drug response - up to 60-65% of PAD patients demonstrate resistance to aspirin or clopidogrel. The absence of personalized, objective thromboprophylaxis strategies represents a critical gap in PAD management.
TECHNOLOGY: THROMBOELASTOGRAPHY WITH PLATELET MAPPING (TEG-PM)
TEG-PM is a whole-blood, point-of-care assay providing real-time assessment of a patient's complete coagulation profile. TEG characterizes clot initiation (R time), kinetics (K time, α angle), maximum clot strength (mA), and fibrinolysis (Lysis 30), enabling discrimination between hypo- and hypercoagulable states. Platelet Mapping quantifies platelet inhibition via arachidonic acid (AA) and adenosine diphosphate (ADP) agonist assays, yielding a platelet inhibition percentage that reflects each patient's real-time pharmacodynamic response to antiplatelet therapy. All samples are analyzed on a TEG 6s (Haemonetics®) Hemostasis Analyzer within validated processing windows using citrated and sodium heparin tubes.
PRELIMINARY DATA A prospective observational study of 162 PAD patients identified platelet inhibition as the sole independent predictor of post-revascularization thrombosis. A threshold of 29% identified high thrombotic risk (87% sensitivity, 71% specificity; AUC 0.756), while an upper threshold of 86% identified elevated bleeding risk (71% sensitivity, 87% specificity; AUC 0.84), defining a therapeutic window of 29-86%. A separate analysis of 521 TEG-PM samples from 143 PAD patients confirmed extensive inter-patient variability in platelet inhibition response, supporting the case against uniform treatment strategies.
Pilot implementation in 34 patients produced a thrombosis rate of 3.8% vs. 20% under SOC (p<0.05) with no increase in bleeding. A subsequent prospective comparison of 70 protocol-guided patients against 267 SOC patients demonstrated thrombosis rates of 4.3% vs. 20.6%, with fewer bleeding events in the protocol-guided arm.
THE TARGET PROTOCOL The Thromboprophylaxis for Arterial Revascularization to Guide Elderly Therapy (TARGET) protocol integrates serial TEG-PM assessments into clinical decision-making to maintain platelet inhibition within the 29-86% therapeutic window throughout 12 months. TEG-PM is first performed at 7 days postoperatively. If platelet inhibition falls outside the therapeutic range, the antiplatelet regimen is adjusted per a prespecified escalation/de-escalation algorithm, with repeat testing 7 days after each change. Once the target range is achieved, monitoring continues at 1, 3, 6, 9, and 12 months with adjustments made as needed. Patients refractory to stepwise adjustments are referred to hematology once for further evaluation and remain enrolled on their last recommended regimen. All patients who receive clopidogrel for at least 7 days undergo VerifyNow P2Y12 resistance testing at a single timepoint to inform agent selection. Control arm patients receive SOC therapy throughout; TEG-PM is collected for data purposes only with no medication adjustments made.
COAGULATION TESTING SCHEDULE TEG-PM samples are collected at: preoperative baseline, 1 week (7-20 days post-op), 1 month (27-47 days), 3 months (85-105 days), 6 months (180-210 days), 9 months (270-295 days), and 12 months (365-390 days). Unscheduled samples may be collected at the PI's discretion in response to clinical events such as thrombosis, bleeding, or inconclusive results.
- Conditions
- Peripheral Arterial Disease (PAD), Amputation, Thrombosis, Thrombosis (Stent Thrombosis), Platelet Aggregation Inhibitors, Thromboelastography (TEG)
- Being tested
- Aspirin, Clopidogrel, Ticagrelor, Rivaroxaban, Thromboelastography with Platelet Mapping
- Keywords
- Peripheral Artery Disease Thromboprophylaxis, Personalizing Blood Thinners, Clopidogrel Resistance, Thromboelastography with Platelet Mapping (TEG-PM), Graft/ Stent Thrombosis, Platelet Inhibition
- Medical subject headings
- Peripheral Arterial Disease, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called Acetylsalicylic Acid; ASA
Aspirin is an oral antiplatelet agent that inhibits cyclooxygenase-mediated thromboxane A2 production, reducing platelet aggregation. It serves as the foundational antiplatelet agent in both study arms following lower extremity endovascular revascularization.
ClopidogrelDrug
Also called Plavix
Clopidogrel is an oral P2Y12 platelet inhibitor used as part of postoperative antiplatelet therapy following lower extremity endovascular revascularization. In the SOC arm, it is administered as part of a fixed dual antiplatelet regimen. In the TARGET arm, it serves as an initial antiplatelet agent, with continuation or substitution determined by TEG-PM platelet inhibition results and VerifyNow P2Y12 resistance testing. If clopidogrel resistance is identified or platelet inhibition remains below the 29% threshold, clopidogrel may be replaced with ticagrelor per the study algorithm.
TicagrelorDrug
Also called Brilinta
Ticagrelor is an oral, reversible P2Y12 platelet inhibitor. Unlike clopidogrel, ticagrelor demonstrates minimal resistance and more consistent platelet inhibition, making it a preferred escalation agent.
RivaroxabanDrug
Also called Xarelto
Rivaroxaban is an oral factor Xa inhibitor used in both study arms. In the SOC arm, low-dose rivaroxaban combined with aspirin represents one of two standard postoperative regimens, administered per surgeon preference. In the TARGET arm, rivaroxaban may be initiated or substituted based on TEG-PM platelet inhibition results and clopidogrel resistance testing findings. Full-dose rivaroxaban is reserved for patients who remain persistently hypercoagulable despite stepwise antiplatelet escalation, prior to hematology referral.
Thromboelastography with Platelet MappingDevice
Also called TEG-PM, TEG 6s, Haemonetics TEG 6s Hemostasis Analyzer
Whole-blood, viscoelastic point-of-care assay used to assess real-time coagulation status and platelet function.
| Study group | Role | What they receive |
|---|---|---|
| TARGET | Experimental | Participants receive postoperative antiplatelet therapy consistent with standard of care, with regimen adjustments guided by serial TEG-PM (Thromboelastography with Platelet Mapping) assessments. The goal is to maintain platelet inhibition within a therapeutic window of 29-86%. If platelet inhibition falls outside this range at any timepoint, the antiplatelet regimen is escalated or de-escalated per a prespecified algorithm. TEG-PM testing occurs at 1 week, 1, 3, 6, 9, and 12 months postoperatively, with repeat testing 7 days after any medication change. Receives: Drug: Aspirin; Drug: Clopidogrel; Drug: Ticagrelor; Drug: Rivaroxaban; Device: Thromboelastography with Platelet Mapping |
| Standard of Care (SOC) | Active comparator | Participants receive standard postoperative antiplatelet therapy per the treating surgeon's preference (dual antiplatelet therapy or aspirin combined with low-dose rivaroxaban) for the 12-month follow-up period. TEG-PM testing is performed at all scheduled timepoints for data collection purposes only; no medication adjustments are made based on results. Receives: Drug: Aspirin; Drug: Clopidogrel; Drug: Ticagrelor; Drug: Rivaroxaban; Device: Thromboelastography with Platelet Mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Arterial Thrombosis in the Treated Limb
Proportion of participants experiencing graft or stent thrombosis in the revascularized limb, compared between the TARGET and SOC arms. Thrombosis will be assessed via vascular studies including ankle-brachial index, arterial duplex, and toe pressure at scheduled follow-up visits.
Measured: 12 months post-revascularization
Secondary outcomes (4)
Amputation-Free Survival (AFS)
Measured: 12 months post-revascularization
All-Cause Mortality
Measured: 12 months post-revascularization
Reintervention Rate
Measured: 12 months post-revascularization
Incidence of Bleeding Events
Measured: 12 months post-revascularization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start29 Apr 2025
- Primary completion29 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial Disease (PAD)Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized postoperatively in a 1:1 ratio into one of two groups: the TARGET protocol (interventional arm) or the standard of care (control arm). Randomization uses random block sizes of 2 or 4, stratified by sex and site. Both groups are followed in parallel for 12 months post-revascularization.
- Masking
- None (open label)
- Enrolment
- 484 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anahita Dua, MBCHB, MBA, MSC, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613840
- Sponsor's protocol ID
- 2024P002975
- Status last verified
- Sep 2026
- First submitted
- 13 May 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Lee I, Suarez S, Hall R, Majumdar M, Bellomo T, Jessula S, Nuzzolo K, Jefferson DM, Zacharias N, Dua A. Optimizing platelet inhibition in peripheral artery disease: A comparison of mono-antiplatelet therapy and dual-antiplatelet therapy using thromboelastography. Vascular. 2025 Feb;33(1):3-18. doi: 10.1177/17085381241237005. Epub 2024 Mar 5.
PubMed 38441042Bates KJ, Moore MM, Cibotti-Sun M. 2024 Lower Extremity Peripheral Artery Disease Guideline-at-a-Glance. J Am Coll Cardiol. 2024 Jun 18;83(24):2605-2609. doi: 10.1016/j.jacc.2024.04.003. Epub 2024 May 14. No abstract available.
PubMed 38752900Suarez S, Agrawal A, Patel S, Grobman B, Ghandour S, Morena L, Rodriguez A, Machlus K, Roy T, Eagleton M, Dua A. The Impact of Sex on Antiplatelet and Anticoagulant Thromboprophylaxis in Patients With Peripheral Artery Disease Post-revascularization. Ann Surg. 2024 Sep 1;280(3):463-472. doi: 10.1097/SLA.0000000000006375. Epub 2024 Jun 11.
PubMed 38860382Suarez Ferreira S, Agrawal A, Lee I, Rodriguez A, Cieri I, Young E, Patel S, Ghandour S, Morena L, Hagos F, Grobman B, Machlus K, Roy T, Dua A. The Use of Clot Strength as a Predictor of Thrombosis in Peripheral Artery Disease. Ann Vasc Surg. 2024 Dec;109:273-283. doi: 10.1016/j.avsg.2024.06.041. Epub 2024 Jul 26.
PubMed 39069123Majumdar M, Hall RP, Feldman Z, Goudot G, Sumetsky N, Jessula S, Kirshkaln A, Bellomo T, Chang D, Cardenas J, Patell R, Eagleton M, Dua A. Predicting Arterial Thrombotic Events Following Peripheral Revascularization Using Objective Viscoelastic Data. J Am Heart Assoc. 2023 Jan 3;12(1):e027790. doi: 10.1161/JAHA.122.027790. Epub 2022 Dec 24.
PubMed 36565191Majumdar M, Waller D, Poyant J, McElroy I, Lella S, Feldman ZM, Levine E, Kim Y, Nuzzolo K, Kirshkaln A, DeCarlo C, Dua A. Variability of antiplatelet response in patients with peripheral artery disease. J Vasc Surg. 2023 Jan;77(1):208-215.e3. doi: 10.1016/j.jvs.2022.08.015. Epub 2022 Aug 24.
PubMed 36028157Hess CN, Norgren L, Ansel GM, Capell WH, Fletcher JP, Fowkes FGR, Gottsater A, Hitos K, Jaff MR, Nordanstig J, Hiatt WR. A Structured Review of Antithrombotic Therapy in Peripheral Artery Disease With a Focus on Revascularization: A TASC (InterSociety Consensus for the Management of Peripheral Artery Disease) Initiative. Circulation. 2017 Jun 20;135(25):2534-2555. doi: 10.1161/CIRCULATIONAHA.117.024469.
PubMed 28630267Owens CD, Ho KJ, Conte MS. Lower extremity vein graft failure: a translational approach. Vasc Med. 2008 Feb;13(1):63-74. doi: 10.1177/1358863X07083432.
PubMed 18372442Aronow WS. Peripheral arterial disease in the elderly. Clin Interv Aging. 2007;2(4):645-54. doi: 10.2147/cia.s2412.
PubMed 18225466
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalizing Post Surgical Thromboprophylaxis for Patients With Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT07613840
- Acronym / sponsor ID
- 2024P002975
- Conditions
- Peripheral Arterial Disease (PAD), Amputation, Thrombosis, Thrombosis (Stent Thrombosis), Platelet Aggregation Inhibitors, Thromboelastography (TEG)
- Keywords
- Peripheral Artery Disease Thromboprophylaxis, Personalizing Blood Thinners, Clopidogrel Resistance, Thromboelastography with Platelet Mapping (TEG-PM), Graft/ Stent Thrombosis, Platelet Inhibition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 484 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- 29 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 29 May 2026 (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.
The goal of this clinical trial is to determine whether a personalised blood clot prevention plan is more effective than standard treatment in adults with peripheral artery disease (PAD) who have undergone a procedure to restore blood flow to their legs.
The main questions it aims to answer are:
- Does the personalized plan lower the rate of blood clots in the treated leg one year after the procedure?
- Does the personalized plan lower rates of amputation, repeat procedures, bleeding, and death compared to standard treatment?
Researchers will compare the personalized TARGET plan which uses a blood test to tailor each person's blood clot prevention medication to the standard treatment to see if the personalized approach works better.
Participants will:
- Be randomly assigned to either the personalized TARGET plan or standard treatment after their procedure
- Have blood tests at 1 week and at 1, 3, 6, 9, and 12 months after their procedure
- Have medications adjusted based on blood test results if assigned to the TARGET group
Detailed description
SCIENTIFIC RATIONALE Graft and stent thrombosis occurs in approximately 17% of PAD patients within 6 months of lower extremity revascularization and is the leading driver of amputation and death in this population. Current standard-of-care (SOC) thromboprophylaxis applies a uniform antiplatelet regimen despite well-documented inter-patient variability in platelet reactivity and drug response - up to 60-65% of PAD patients demonstrate resistance to aspirin or clopidogrel. The absence of personalized, objective thromboprophylaxis strategies represents a critical gap in PAD management.
TECHNOLOGY: THROMBOELASTOGRAPHY WITH PLATELET MAPPING (TEG-PM)
TEG-PM is a whole-blood, point-of-care assay providing real-time assessment of a patient's complete coagulation profile. TEG characterizes clot initiation (R time), kinetics (K time, α angle), maximum clot strength (mA), and fibrinolysis (Lysis 30), enabling discrimination between hypo- and hypercoagulable states. Platelet Mapping quantifies platelet inhibition via arachidonic acid (AA) and adenosine diphosphate (ADP) agonist assays, yielding a platelet inhibition percentage that reflects each patient's real-time pharmacodynamic response to antiplatelet therapy. All samples are analyzed on a TEG 6s (Haemonetics®) Hemostasis Analyzer within validated processing windows using citrated and sodium heparin tubes.
PRELIMINARY DATA A prospective observational study of 162 PAD patients identified platelet inhibition as the sole independent predictor of post-revascularization thrombosis. A threshold of 29% identified high thrombotic risk (87% sensitivity, 71% specificity; AUC 0.756), while an upper threshold of 86% identified elevated bleeding risk (71% sensitivity, 87% specificity; AUC 0.84), defining a therapeutic window of 29-86%. A separate analysis of 521 TEG-PM samples from 143 PAD patients confirmed extensive inter-patient variability in platelet inhibition response, supporting the case against uniform treatment strategies.
Pilot implementation in 34 patients produced a thrombosis rate of 3.8% vs. 20% under SOC (p<0.05) with no increase in bleeding. A subsequent prospective comparison of 70 protocol-guided patients against 267 SOC patients demonstrated thrombosis rates of 4.3% vs. 20.6%, with fewer bleeding events in the protocol-guided arm.
THE TARGET PROTOCOL The Thromboprophylaxis for Arterial Revascularization to Guide Elderly Therapy (TARGET) protocol integrates serial TEG-PM assessments into clinical decision-making to maintain platelet inhibition within the 29-86% therapeutic window throughout 12 months. TEG-PM is first performed at 7 days postoperatively. If platelet inhibition falls outside the therapeutic range, the antiplatelet regimen is adjusted per a prespecified escalation/de-escalation algorithm, with repeat testing 7 days after each change. Once the target range is achieved, monitoring continues at 1, 3, 6, 9, and 12 months with adjustments made as needed. Patients refractory to stepwise adjustments are referred to hematology once for further evaluation and remain enrolled on their last recommended regimen. All patients who receive clopidogrel for at least 7 days undergo VerifyNow P2Y12 resistance testing at a single timepoint to inform agent selection. Control arm patients receive SOC therapy throughout; TEG-PM is collected for data purposes only with no medication adjustments made.
COAGULATION TESTING SCHEDULE TEG-PM samples are collected at: preoperative baseline, 1 week (7-20 days post-op), 1 month (27-47 days), 3 months (85-105 days), 6 months (180-210 days), 9 months (270-295 days), and 12 months (365-390 days). Unscheduled samples may be collected at the PI's discretion in response to clinical events such as thrombosis, bleeding, or inconclusive results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized postoperatively in a 1:1 ratio into one of two groups: the TARGET protocol (interventional arm) or the standard of care (control arm). Randomization uses random block sizes of 2 or 4, stratified by sex and site. Both groups are followed in parallel for 12 months post-revascularization.
| Arm | Type | Receives |
|---|---|---|
| TARGET | Experimental | Drug: Aspirin, Drug: Clopidogrel, Drug: Ticagrelor, Drug: Rivaroxaban, Device: Thromboelastography with Platelet MappingParticipants receive postoperative antiplatelet therapy consistent with standard of care, with regimen adjustments guided by serial TEG-PM (Thromboelastography with Platelet Mapping) assessments. The goal is to maintain platelet inhibition within a therapeutic window of 29-86%. If platelet inhibition falls outside this range at any timepoint, the antiplatelet regimen is escalated or de-escalated per a prespecified algorithm. TEG-PM testing occurs at 1 week, 1, 3, 6, 9, and 12 months postoperatively, with repeat testing 7 days after any medication change. |
| Standard of Care (SOC) | Active comparator | Drug: Aspirin, Drug: Clopidogrel, Drug: Ticagrelor, Drug: Rivaroxaban, Device: Thromboelastography with Platelet MappingParticipants receive standard postoperative antiplatelet therapy per the treating surgeon's preference (dual antiplatelet therapy or aspirin combined with low-dose rivaroxaban) for the 12-month follow-up period. TEG-PM testing is performed at all scheduled timepoints for data collection purposes only; no medication adjustments are made based on results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a named arterial extremity injury or named vessel revascularization for atherosclerosis requiring open and/or closed revascularization.
- Patients at the age of 18 or older
Key exclusion criteria (7 listed)
- Patients who are younger than 18 years old
- Known pregnancy (females of childbearing potential will have a pregnancy test prior to surgery as per standard of care)
- Prisoners, defined as those who have been directly admitted from a correctional facility.
- No atherosclerosis
- Subject has active stomach ulcers
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 |
|---|---|---|
| AspirinAlso: Acetylsalicylic Acid; ASAAspirin is an oral antiplatelet agent that inhibits cyclooxygenase-mediated thromboxane A2 production, reducing platelet aggregation. It serves as the foundational antiplatelet agent in both study arms following lower extremity endovascular revascularization. | Drug | Standard of Care (SOC), TARGET |
| ClopidogrelAlso: PlavixClopidogrel is an oral P2Y12 platelet inhibitor used as part of postoperative antiplatelet therapy following lower extremity endovascular revascularization. In the SOC arm, it is administered as part of a fixed dual antiplatelet regimen. In the TARGET arm, it serves as an initial antiplatelet agent, with continuation or substitution determined by TEG-PM platelet inhibition results and VerifyNow P2Y12 resistance testing. If clopidogrel resistance is identified or platelet inhibition remains below the 29% threshold, clopidogrel may be replaced with ticagrelor per the study algorithm. | Drug | Standard of Care (SOC), TARGET |
| TicagrelorAlso: BrilintaTicagrelor is an oral, reversible P2Y12 platelet inhibitor. Unlike clopidogrel, ticagrelor demonstrates minimal resistance and more consistent platelet inhibition, making it a preferred escalation agent. | Drug | Standard of Care (SOC), TARGET |
| RivaroxabanAlso: XareltoRivaroxaban is an oral factor Xa inhibitor used in both study arms. In the SOC arm, low-dose rivaroxaban combined with aspirin represents one of two standard postoperative regimens, administered per surgeon preference. In the TARGET arm, rivaroxaban may be initiated or substituted based on TEG-PM platelet inhibition results and clopidogrel resistance testing findings. Full-dose rivaroxaban is reserved for patients who remain persistently hypercoagulable despite stepwise antiplatelet escalation, prior to hematology referral. | Drug | Standard of Care (SOC), TARGET |
| Thromboelastography with Platelet MappingAlso: TEG-PM, TEG 6s, Haemonetics TEG 6s Hemostasis AnalyzerWhole-blood, viscoelastic point-of-care assay used to assess real-time coagulation status and platelet function. | Device | Standard of Care (SOC), TARGET |
Primary outcome
Incidence of Arterial Thrombosis in the Treated Limb
Time frame: 12 months post-revascularization
Proportion of participants experiencing graft or stent thrombosis in the revascularized limb, compared between the TARGET and SOC arms. Thrombosis will be assessed via vascular studies including ankle-brachial index, arterial duplex, and toe pressure at scheduled follow-up visits.
4 secondary outcomes
Amputation-Free Survival (AFS)
Time frame: 12 months post-revascularization
All-Cause Mortality
Time frame: 12 months post-revascularization
Reintervention Rate
Time frame: 12 months post-revascularization
Incidence of Bleeding Events
Time frame: 12 months post-revascularization
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 11 Sep 2026.
- Background: PubMed 38441042Lee I, Suarez S, Hall R, Majumdar M, Bellomo T, Jessula S, Nuzzolo K, Jefferson DM, Zacharias N, Dua A. Optimizing platelet inhibition in peripheral artery disease: A comparison of mono-antiplatelet therapy and dual-antiplatelet therapy using thromboelastography. Vascular. 2025 Feb;33(1):3-18. doi: 10.1177/17085381241237005. Epub 2024 Mar 5.
- Background: PubMed 38752900Bates KJ, Moore MM, Cibotti-Sun M. 2024 Lower Extremity Peripheral Artery Disease Guideline-at-a-Glance. J Am Coll Cardiol. 2024 Jun 18;83(24):2605-2609. doi: 10.1016/j.jacc.2024.04.003. Epub 2024 May 14. No abstract available.
- Background: PubMed 38860382Suarez S, Agrawal A, Patel S, Grobman B, Ghandour S, Morena L, Rodriguez A, Machlus K, Roy T, Eagleton M, Dua A. The Impact of Sex on Antiplatelet and Anticoagulant Thromboprophylaxis in Patients With Peripheral Artery Disease Post-revascularization. Ann Surg. 2024 Sep 1;280(3):463-472. doi: 10.1097/SLA.0000000000006375. Epub 2024 Jun 11.
- Background: PubMed 39069123Suarez Ferreira S, Agrawal A, Lee I, Rodriguez A, Cieri I, Young E, Patel S, Ghandour S, Morena L, Hagos F, Grobman B, Machlus K, Roy T, Dua A. The Use of Clot Strength as a Predictor of Thrombosis in Peripheral Artery Disease. Ann Vasc Surg. 2024 Dec;109:273-283. doi: 10.1016/j.avsg.2024.06.041. Epub 2024 Jul 26.
- Background: PubMed 36565191Majumdar M, Hall RP, Feldman Z, Goudot G, Sumetsky N, Jessula S, Kirshkaln A, Bellomo T, Chang D, Cardenas J, Patell R, Eagleton M, Dua A. Predicting Arterial Thrombotic Events Following Peripheral Revascularization Using Objective Viscoelastic Data. J Am Heart Assoc. 2023 Jan 3;12(1):e027790. doi: 10.1161/JAHA.122.027790. Epub 2022 Dec 24.
- Background: PubMed 36028157Majumdar M, Waller D, Poyant J, McElroy I, Lella S, Feldman ZM, Levine E, Kim Y, Nuzzolo K, Kirshkaln A, DeCarlo C, Dua A. Variability of antiplatelet response in patients with peripheral artery disease. J Vasc Surg. 2023 Jan;77(1):208-215.e3. doi: 10.1016/j.jvs.2022.08.015. Epub 2022 Aug 24.
- Background: PubMed 28630267Hess CN, Norgren L, Ansel GM, Capell WH, Fletcher JP, Fowkes FGR, Gottsater A, Hitos K, Jaff MR, Nordanstig J, Hiatt WR. A Structured Review of Antithrombotic Therapy in Peripheral Artery Disease With a Focus on Revascularization: A TASC (InterSociety Consensus for the Management of Peripheral Artery Disease) Initiative. Circulation. 2017 Jun 20;135(25):2534-2555. doi: 10.1161/CIRCULATIONAHA.117.024469.
- Background: PubMed 18372442Owens CD, Ho KJ, Conte MS. Lower extremity vein graft failure: a translational approach. Vasc Med. 2008 Feb;13(1):63-74. doi: 10.1177/1358863X07083432.
- Background: PubMed 18225466Aronow WS. Peripheral arterial disease in the elderly. Clin Interv Aging. 2007;2(4):645-54. doi: 10.2147/cia.s2412.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin, Clopidogrel and Ticagrelor in people with Peripheral Arterial Disease (PAD) and Amputation, run by Massachusetts General Hospital at 2 sites in United States.
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 2 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. 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 United States. 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.
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?
Contact Anahita Dua, MBCHB, MBA, MSC (262-565-8247, adua1@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Arterial Thrombosis in the Treated Limb (time frame: 12 months post-revascularization). 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 NCT07613840, which also lists 9 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 11 Sep 2026.