Antiplatelet Therapy for Vascular Disease

(CAPTT Trial)

Overseen By Mark B Effron, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Ochsner Health System

Must be taking: Aspirin, P2Y12 inhibitors

Must not be taking: Anticoagulants

Disqualifiers: Recent PCI, ACS, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 31

Duration: 1 week

100 Participants Needed

Trial Summary

What is the purpose of this trial?

Patients on dual antiplatelet therapy )aspirin plus a P2Y12 inhibitor \[clopidogrel, prasugrel, or ticagrelor\]) undergoing screening or surveilance colonoscopy are at increased risk for bleeding from the procedure. Patients are ussually asked to stop the P2Y12 inhibitor for the procedure. Currently, recommendation is that patients only on a P2Y12 inhibitor be changes to aspirin for the procedure. This pilot study will evaluate if there is a large difference in bleeding between patients only taking aspirin compared with patients only taking a P2Y12 inhibitor. Patinets who participate will randomly be randomly asked to stop either aspirin or the P2Y12 inhibitor 1 week before the procedure. Periprocedural bleeding and bleeding after the procedure for iup to 30 days.

Will I have to stop taking my current medications?

Yes, if you are taking both aspirin and a P2Y12 inhibitor, you will be asked to stop either aspirin or the P2Y12 inhibitor one week before the procedure.

What evidence supports the effectiveness of the drug combination of aspirin and P2Y12 inhibitors for vascular disease?

Research shows that combining aspirin with P2Y12 inhibitors like clopidogrel, prasugrel, or ticagrelor is effective in reducing major cardiovascular events in patients with acute coronary syndromes (heart-related conditions caused by sudden reduced blood flow to the heart). This combination helps prevent blood clots, although it may increase the risk of bleeding. ^{1 2 3 4 5}

Is antiplatelet therapy safe for humans?

Antiplatelet therapy, including drugs like aspirin, clopidogrel, prasugrel, and ticagrelor, is generally safe for humans but can increase the risk of bleeding. Prasugrel may cause more major bleeding compared to clopidogrel and ticagrelor, so it is often recommended for patients with a low risk of bleeding. ^{4 6 7 8 9}

How is the drug combination of aspirin and P2Y12 inhibitors unique for treating vascular disease?

The combination of aspirin and newer P2Y12 inhibitors like prasugrel and ticagrelor is unique because it offers more rapid and consistent platelet inhibition compared to older treatments like clopidogrel, which can lead to better prevention of blood clots in patients with vascular disease. However, prasugrel may have a higher risk of bleeding in certain patients, such as those over 75 years old or with low body weight. ^{1 5 10 11 12}

Eligibility Criteria

This trial is for patients with vascular diseases who are on dual antiplatelet therapy (aspirin plus a P2Y12 inhibitor) and need a colonoscopy. They should be able to stop one of their medications before the procedure. Specific inclusion or exclusion criteria were not provided.

Inclusion Criteria

I am scheduled for a routine colonoscopy.

I am 45 years old or older.

My heart condition is stable, and I haven't changed my heart medication in the last 30 days.

Exclusion Criteria

Hematocrit < 30% and hemoglobin < 10 mg/dL

I have a high risk of heart problems, including recent severe chest pain or heart surgery.

I am on long-term blood thinners.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to stop either aspirin or the P2Y12 inhibitor 1 week before the colonoscopy procedure

1 week

1 visit (in-person) for the procedure

Follow-up

Participants are monitored for periprocedural bleeding and bleeding after the procedure

4 weeks

Follow-up monitoring for up to 30 days

Treatment Details

Interventions

• Aspirin
• P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)

Trial Overview The study tests whether stopping aspirin or a P2Y12 inhibitor (clopidogrel, prasugrel, ticagrelor) affects bleeding risk in patients undergoing colonoscopy. Participants will be randomly chosen to stop either medication one week prior to the procedure.

Participant Groups

Group I: P2Y12 inhibitor only Experimental Treatment 1 Intervention

Participants receiving a P2Y12 inhibitor only at time of the colonoscopy

Group II: Aspirin only Active Control 1 Intervention

Participants receiving aspirin only at time of the colonoscopy

Aspirin is already approved in European Union, United States, Canada, China for the following indications:

Approved in European Union as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Preeclampsia prevention

Approved in United States as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Preeclampsia prevention

Approved in Canada as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Preeclampsia prevention

Approved in China as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention

Who Is Running the Clinical Trial?

Ochsner Health System

Lead Sponsor

Trials

97

Recruited

91,900+

References

1. United States pubmed.ncbi.nlm.nih.gov

Advances in antiplatelet therapy. [2016]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Use of Clopidogrel, Prasugrel, or Ticagrelor and Patient Outcome after Acute Coronary Syndrome in Austria from 2015 to 2017. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

[Differentiated antiplatelet therapy for acute coronary syndromes]. [2018]

4. India pubmed.ncbi.nlm.nih.gov

P2Y12 inhibitors in acute coronary syndromes: which and when? [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

[Prasugrel]. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and pharmacodynamics of ticagrelor and prasugrel in healthy male Korean volunteers. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of newer P2Y12 inhibitors for acute coronary syndrome: a network meta-analysis. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Comparative Efficacy and Safety of Oral P2Y12 Inhibitors in Acute Coronary Syndrome: Network Meta-Analysis of 52 816 Patients From 12 Randomized Trials. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

High-dose aspirin in dogs increases vascular resistance with limited additional anti-platelet effect when combined with potent P2Y12 inhibition. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Prasugrel in the treatment of acute coronary syndrome. [2021]

11. Germany pubmed.ncbi.nlm.nih.gov

[Update: oral platelet inhibitors in cardiology]. [2021]

12. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Experience with Prasugrel in the Treatment of Patients with Acute Coronary Syndrome]. [2019]