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Carbasalate Calcium

This article discusses the use of Carbasalate Calcium in clinical trials, specifically in the context of stroke prevention for patients with atrial fibrillation who have recently experienced an intracerebral hemorrhage while on anticoagulation therapy. The trials aim to compare the effectiveness and safety of various antithrombotic treatments, including Carbasalate Calcium, in this high-risk patient population.

Table of Contents

What is Carbasalate Calcium?

Carbasalate calcium is a medication that belongs to a group of drugs known as antiplatelet agents[1]. It is closely related to aspirin (acetylsalicylic acid) and works in a similar way to prevent blood clots from forming. This medication is often used in situations where doctors want to reduce the risk of blood clots but may be concerned about using stronger blood thinners.

Medical Conditions Treated

The clinical trial information suggests that carbasalate calcium is being studied for use in patients with two main conditions[1]:

  • Atrial Fibrillation (AF): This is a heart rhythm disorder where the upper chambers of the heart beat irregularly. It can increase the risk of blood clots forming in the heart.
  • Cerebral Hemorrhage: Also known as an intracerebral hemorrhage (ICH), this is a type of stroke caused by bleeding within the brain tissue.

Carbasalate calcium is being considered as a treatment option for patients who have both atrial fibrillation and a history of cerebral hemorrhage while on anticoagulant therapy (stronger blood thinners).

Usage in Clinical Trial

In the clinical trial described (NCT02565693), carbasalate calcium is being studied as one of the possible treatment options for patients who have experienced a brain bleed (intracerebral hemorrhage) while taking anticoagulants for atrial fibrillation[1]. The trial is comparing different approaches to prevent future strokes in these high-risk patients:

  1. Using a newer anticoagulant called apixaban
  2. Using antiplatelet drugs like carbasalate calcium
  3. Not using any blood-thinning medications

Dosage Information

According to the trial information, when carbasalate calcium is used, the dosage is 100 mg once daily[1]. However, it’s important to note that dosages can vary depending on individual patient factors, and you should always follow your doctor’s specific instructions.

Comparison with Other Treatments

The clinical trial compares carbasalate calcium with other treatment options[1]:

  • Apixaban: This is a newer type of anticoagulant that might be more effective at preventing strokes but could potentially increase bleeding risk.
  • Other antiplatelet drugs: These include aspirin, clopidogrel, and dipyridamole. They work similarly to carbasalate calcium but may have slightly different effects or side effect profiles.
  • No antithrombotic treatment: This means not using any blood-thinning medications, which might reduce bleeding risk but could increase the risk of blood clots.

Potential Benefits and Risks

The potential benefits of using carbasalate calcium in this context include[1]:

  • Reducing the risk of ischemic stroke (strokes caused by blood clots)
  • Potentially lower risk of bleeding compared to stronger anticoagulants

However, there are also potential risks to consider:

  • It may not be as effective as stronger anticoagulants in preventing strokes in patients with atrial fibrillation
  • There is still a risk of bleeding, including recurrent intracerebral hemorrhage

The clinical trial aims to better understand these benefits and risks to help guide future treatment decisions for patients in this complex situation.

Aspect Details
Study Type Randomized, open-label, multi-center clinical trial with masked outcome assessment
Patient Population 100 adults with atrial fibrillation and recent intracerebral hemorrhage during anticoagulation treatment
Intervention Apixaban vs. antiplatelet therapy (including Carbasalate Calcium) or no antithrombotic drugs
Carbasalate Calcium Dosage 100 mg once daily, alone or with dipyridamole 200 mg twice daily
Primary Outcome Vascular death or non-fatal stroke during follow-up
Follow-up Duration 12 to 72 months
Key Secondary Outcomes All-cause death, various stroke types, major hemorrhage, systemic embolism, functional outcome

FAQ

  • What is the purpose of the clinical trial involving Carbasalate Calcium? The clinical trial aims to compare different antithrombotic treatments, including Carbasalate Calcium, for stroke prevention in patients with atrial fibrillation who have recently experienced an intracerebral hemorrhage while on anticoagulation therapy. The study seeks to find the best approach to prevent ischemic strokes while minimizing the risk of recurrent bleeding.
  • How is Carbasalate Calcium used in the trial? Carbasalate Calcium is used as one of the possible treatments in the comparator arm of the study. Patients may receive Carbasalate Calcium 100 mg once daily, either alone or in combination with dipyridamole 200 mg twice daily.
  • What are the other treatment options being compared to Carbasalate Calcium? The trial compares Carbasalate Calcium to other treatments such as apixaban (an anticoagulant), acetylsalicylic acid, clopidogrel, dipyridamole, or no antithrombotic treatment at all. The goal is to determine which approach offers the best balance of stroke prevention and safety for this specific patient group.
  • What are the main outcomes being measured in the trial? The primary outcome of the trial is the number of patients who experience vascular death or non-fatal stroke. Secondary outcomes include all-cause death, different types of strokes, major extracranial hemorrhage, systemic embolism, myocardial infarction, and functional outcome as measured by the modified Rankin Scale.
  • How long will patients be followed in this clinical trial? Patients in this clinical trial will be followed for a minimum of 12 months and a maximum of 72 months (6 years). This extended follow-up period allows researchers to assess the long-term effects and safety of the different treatment options, including Carbasalate Calcium.

Ongoing Clinical Trials on Carbasalate Calcium

  • Study Comparing Apixaban and Carbasalate Calcium for Patients with Aortic Valve Replacement Due to Heart Disease

    Recruiting

    1 1 1 1
    Investigated drugs:
    France

  • Study on Colchicine and Aspirin for Improving Heart Health in Adults with Type 2 Diabetes Without Previous Heart Events

    Recruiting

    1 1 1
    Investigated drugs:
    Denmark Finland France Greece Italy Portugal

  • Study on Aspirin and Metformin for Patients with Locally Advanced Rectal Cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on Stopping or Continuing Clopidogrel, Carbasalate Calcium, and Dipyridamole for Young Patients After Stroke Without a Known Cause

    Recruiting

    1 1 1 1
    Investigated drugs:
    The Netherlands

  • Study Comparing Givinostat and Hydroxyurea for Patients with High-Risk Polycythemia Vera

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Bulgaria Croatia France Germany Hungary +5

  • Study on Genotype-Guided Treatment with Carbasalate Calcium, Telmisartan, and Rivaroxaban for Patients with Peripheral Arterial Disease

    Not recruiting

    1 1 1 1
    Investigated drugs:
    The Netherlands

  • Study on the Effects of Metoprolol, Prasugrel, and Carbasalate Calcium in Patients with Spontaneous Coronary Artery Dissection

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Atrial Fibrillation: A heart condition characterized by irregular and often rapid heart rate, which increases the risk of stroke and other complications.
  • Intracerebral Hemorrhage: A type of stroke caused by bleeding within the brain tissue, often leading to neurological deficits.
  • Anticoagulation: The process of hindering blood clot formation using medications known as blood thinners.
  • Carbasalate Calcium: An antiplatelet medication used to prevent blood clots, similar to aspirin but potentially easier on the stomach.
  • Ischemic Stroke: A type of stroke caused by a blockage in blood flow to the brain, often due to a blood clot.
  • Apixaban: A type of direct oral anticoagulant (DOAC) used to prevent blood clots and reduce stroke risk in patients with atrial fibrillation.
  • Systemic Embolism: A condition where a blood clot forms in one part of the body and travels through the bloodstream to block a blood vessel in another part of the body.
  • Modified Rankin Scale: A scale used to measure the degree of disability or dependence in daily activities of people who have suffered a stroke or other neurological disability.
  • Vascular Death: Death caused by cardiovascular events such as stroke, heart attack, or other blood vessel-related issues.
  • Clinical Equipoise: A state of genuine uncertainty among medical experts about which treatment is most beneficial for a particular condition.

References

  1. https://clinicaltrials.gov/study/NCT02565693