Clopidogrel Bisulphate – Changing Trends & Top Applications

Clopidogrel Bisulphate stands as a crucial drug that has reshaped cardiovascular treatment. It is a potent antiplatelet agent that plays a key role in preventing blood clots, thereby reducing the risk of heart attacks and strokes in patients with cardiovascular diseases.

With its widespread adoption in clinical practice, Clopidogrel Bisulphate has become a cornerstone in dual antiplatelet therapy (DAPT). It is often prescribed alongside aspirin for patients undergoing stent implantation, angioplasty, or post-myocardial infarction care. The drug's impact on thrombotic event prevention makes it an indispensable pharmaceutical compound backed by extensive research and regulatory approvals worldwide.

In this blog, we explore the therapeutic applications and demand trends of Clopidogrel Bisulphate, shedding light on why it remains a preferred choice for cardiovascular protection.

Chemical Properties of Clopidogrel Bisulphate

Clopidogrel Bisulphate is a widely used antiplatelet agent that inhibits platelet aggregation. It plays a critical role in preventing thrombotic cardiovascular events such as heart attacks and strokes. Here is a comprehensive breakdown of its chemical and pharmacological properties.

• IUPAC Name: Methyl (S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate bisulfate
• Molecular Formula: C16H16ClNO2·H2SO4
• Molecular Weight: 419.90 g/mol
• CAS Number: 135046-48-9
• Structure: Composed of a thienopyridine core, a chlorophenyl moiety, and an ester functional group, contributing to its antiplatelet activity.
• Isomerism: It exists as a racemic mixture, but only the (S) enantiomer is pharmacologically active.
• Appearance: White to off-white crystalline powder.
• Odor: Odorless.
• Boiling Point: Decomposes before reaching a distinct boiling point.
• Density: Varies depending on hydration state; generally around 1.4 g/cm³ in solid form.
• Solubility:
  • Freely soluble in methanol and ethanol.
  • Slightly soluble in water.
  • Practically insoluble in ethyl acetate and non-polar solvents.
• Refractive Index: Not applicable (solid form).
• Flash Point: Not applicable (solid form).
• Stability: Chemically stable under normal pharmaceutical storage conditions but sensitive to moisture and light.
• Degradation Factors: Can degrade under strong acidic or alkaline conditions; oxidizing agents may affect stability.
• Storage Conditions: Store in a tightly sealed container at room temperature (15-30°C), protected from light, moisture, and heat.
• Natural Source: Synthetic compound, not naturally derived.
• Synthesis Method: Produced through multi-step organic synthesis, including thienopyridine ring formation, chlorination, and esterification, followed by conversion to the bisulphate salt to enhance solubility and bioavailability.

Changing Demand Trends for Clopidogrel Bisulphate

The demand for Clopidogrel Bisulphate, a widely used antiplatelet drug, remains strong globally, with steady trade activity across major pharmaceutical markets. From August 2023 to July 2024, global exports totaled 457 shipments, reflecting a 2% growth over the previous year. 

Meanwhile, imports declined by 12%, with 426 shipments recorded from March 2023 to February 2024. While the overall demand remains high, short-term fluctuations in trade suggest shifts in procurement strategies and inventory management by pharmaceutical manufacturers.

India continues to dominate Clopidogrel Bisulphate exports, accounting for 5,861 shipments, far surpassing Malta (43 shipments) and Mexico (24 shipments). On the import side, Brazil leads with 621 shipments, followed by Pakistan (574 shipments) and Bangladesh (286 shipments). These trends indicate that South Asia and Latin America are key regions driving demand, likely due to increasing cardiovascular disease prevalence and growing generic pharmaceutical industries.

In July 2024, exports saw a 5% year-on-year increase but declined 23% sequentially from last month, suggesting temporary supply chain adjustments. Similarly, in February 2024, imports dropped 30% year-on-year and 58% from January 2024, reflecting possible stockpiling or shifting procurement cycles.

Despite recent import declines, the long-term demand for Clopidogrel Bisulphate remains robust. The rising burden of cardiovascular diseases, expansion of generic drug production, and government healthcare initiatives in emerging markets are expected to sustain strong demand. With India maintaining a dominant supply position, global pharmaceutical manufacturers will continue to rely on stable sourcing channels to meet healthcare needs.

Key Applications of Clopidogrel Bisulphate

Clopidogrel Bisulphate is a widely prescribed antiplatelet agent used to prevent blood clot-related complications in cardiovascular patients. By inhibiting platelet aggregation, it plays a crucial role in reducing the risk of heart attacks, strokes, and other thrombotic events. Here are its key applications across various medical conditions and treatments.

1. Acute Coronary Syndrome (ACS) Treatment

Clopidogrel Bisulphate is a first-line therapy for ACS, including unstable angina and non-ST elevation myocardial infarction (NSTEMI). It is commonly prescribed alongside aspirin in dual antiplatelet therapy (DAPT) to prevent further clot formation. Studies show that DAPT reduces cardiovascular death risk by 20% in ACS patients.

2. Post-Myocardial Infarction (Heart Attack) Management

Patients recovering from a myocardial infarction (heart attack) are at a high risk of recurrent clot formation. Clopidogrel Bisulphate significantly lowers this risk by inhibiting platelet activation, reducing the chance of secondary cardiovascular events. It has been shown to reduce reinfarction rates by up to 20% when used in combination with aspirin.

3. Ischemic Stroke Prevention

For patients who have suffered an ischemic stroke, Clopidogrel Bisulphate helps prevent recurrent cerebrovascular events by improving blood flow and minimizing clot formation. Clinical trials indicate that long-term use of Clopidogrel reduces stroke recurrence risk by approximately 28% compared to placebo.

4. Peripheral Artery Disease (PAD) Management

Clopidogrel Bisulphate is recommended for patients with peripheral artery disease (PAD) to prevent arterial blockages in the limbs. By enhancing blood circulation, it reduces the risk of critical limb ischemia and amputation, significantly improving patient mobility and quality of life.

5. Post-Stent Implantation (Dual Antiplatelet Therapy - DAPT)

After coronary stent implantation, there is a high risk of stent thrombosis, which can lead to heart attacks or sudden cardiac death. Clopidogrel is an essential component of DAPT, reducing the incidence of stent-related complications. Clinical guidelines recommend 12 months of DAPT therapy, significantly lowering adverse cardiovascular events.

6. Atrial Fibrillation (AF) in Patients Ineligible for Oral Anticoagulants

For patients with atrial fibrillation (AF) who cannot tolerate oral anticoagulants like warfarin, Clopidogrel Bisulphate is an effective alternative for stroke prevention. It is often combined with aspirin to reduce clot formation in high-risk AF patients.

7. Coronary Artery Bypass Grafting (CABG) and Post-Surgical Clot Prevention

Clopidogrel Bisulphate is prescribed after coronary artery bypass grafting (CABG) to prevent graft occlusion and improve long-term vessel patency. It ensures smooth blood flow through the bypass grafts, reducing post-surgical complications.

8. Treatment of Drug-Eluting Stent (DES) Thrombosis

Patients with drug-eluting stents (DES) are at risk of late thrombosis. Clopidogrel, in combination with aspirin or ticagrelor, minimizes the chances of clotting within the stent. Studies suggest that prolonged antiplatelet therapy in DES patients lowers stent thrombosis risk by over 50%.

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