AGGRENOX is a combination antiplatelet agent intended for oral administration. Each hard gelatin capsule contains 200 mg dipyridamole in an extended-release form and 25 mg aspirin, as an immediate-release sugar-coated tablet. In addition, each capsule contains the following inactive ingredients: acacia, aluminum stearate, colloidal silicon dioxide, corn starch, dimethicone, hypromellose, hypromellose phthalate, lactose monohydrate, methacrylic acid copolymer, microcrystalline cellulose, povidone, stearic acid, sucrose, talc, tartaric acid, titanium dioxide and triacetin.
Each capsule shell contains gelatin, red iron oxide and yellow iron oxide, titanium dioxide and water.
AGGRENOX is indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis.
Published Studies Related to Aggrenox (Aspirin / Dipyridamole)
Use of aspirin associates with longer primary patency of hemodialysis grafts. [2011.04]
Extended-release dipyridamole plus low-dose aspirin (ERDP/ASA) prolongs primary unassisted graft patency of newly created hemodialysis arteriovenous grafts, but the individual contributions of each component are unknown. Here, we analyzed whether use of aspirin at baseline associated with primary unassisted graft patency among participants in a randomized trial that compared ERDP/ASA and placebo in newly created grafts.
Effects of Aggrenox and aspirin on plasma endothelial nitric oxide synthase and oxidised low-density lipoproteins in patients after ischaemic stroke. The AGgrenox versus aspirin therapy evaluation (AGATE) biomarker substudy. [2011.01]
Plasma endothelial nitric oxide synthase (eNOS), and oxidised low-density lipoproteins (oxLDL) are established biomarkers of atherosclerosis... In the small randomised study, both aspirin and Aggrenox produced fast and sustained recovery of plasma eNOS levels, while only therapy with Aggrenox was associated with oxLDL inhibition late in the trial.
The Japanese aggrenox (extended-release dipyridamole plus aspirin) stroke prevention versus aspirin programme (JASAP) study: a randomized, double-blind, controlled trial. 
BACKGROUND: Despite improvements in treatment, stroke still carries a high death toll and disability in Asia. Extended-release dipyridamole (ER-DP) plus acetylsalicylic acid (ASA) has consistently been shown to be superior over conventional platelet inhibition by ASA. ER-DP plus ASA is well established in the secondary prevention of stroke in a lot of countries including the USA and Europe. DP has an established benefit in the treatment of heart disease in Japan; however, for the prevention of stroke, the fixed-dose combination of ER-DP plus ASA has only been investigated in a small number of patients in Japan... CONCLUSIONS: The results of the study are inconclusive. Noninferiority of ER-DP plus ASA versus ASA could not be established, a difference between treatments could not be shown for the primary end point. Possible reasons for this result include a small sample size, low event rates and too short a treatment duration (ClinicalTrials. gov number, NCT00311402). Copyright (c) 2011 S. Karger AG, Basel.
Safety of fixed-dose aspirin-extended-release dipyridamole in patients with ischemic heart disease. [2010.05.01]
CONCLUSION: A literature review revealed that fixed-dose aspirin-ER dipyridamole was not associated with an increased risk of cardiovascular events in patients with ischemic heart disease. However, individual patient factors merit consideration when choosing an antiplatelet agent for stroke prevention.
Early treatment with aspirin plus extended-release dipyridamole for transient ischaemic attack or ischaemic stroke within 24 h of symptom onset (EARLY trial): a randomised, open-label, blinded-endpoint trial. [2010.02]
BACKGROUND: Little is known about the best antiplatelet treatment immediately after ischaemic stroke or transient ischaemic attack (TIA). The EARLY trial aimed to compare outcome in patients given aspirin plus extended-release dipyridamole twice daily either within 24 h of stroke or TIA or after 7 days of aspirin monotherapy... INTERPRETATION: Early initiation of aspirin plus extended-release dipyridamole within 24 h of stroke onset is likely to be as safe and effective in preventing disability as is later initiation after 7 days. FUNDING: Boehringer Ingelheim. Copyright (c) 2010 Elsevier Ltd. All rights reserved.
Clinical Trials Related to Aggrenox (Aspirin / Dipyridamole)
Drug-drug Interaction Study of Aggrenox and Omeprazole in Normal Volunteers [Completed]
The objective of the current study is to investigate if a drug-drug interaction occurs with
the administration of omeprazole 80 mg q. d. at steady state on the pharmacokinetics of
dipyridamole and the pharmacodynamics of ASA-induced platelet aggregation inhibition
(components of Aggrenox®) when administered every 12 hours at steady state.
Bioequivalence of a New Asasantin Formulation Extended Release (ER) Compared to the Commercially Available Asasantin Formulation (Aggrenox®; Extended Release) in Healthy Male and Female Volunteers [Completed]
Study to establish the bioequivalence of a new formulation of Asasantin ER compared to the
present commercially available Asasantin ER formulation (Aggrenox®)
Study to Compare the Effect of a Combination of Dipyridamole With Sustained Release and Acetyl Salicylic Acid (Aggrenox®) on the Performance Relevant to Safety and on the General Condition of Healthy Volunteers [Completed]
Study to investigate whether psychomotor performance which is necessary for safety driving a
car or operating machinery and safely participating in daily life is changed by Aggrenox®.
Also to investigate whether Aggrenox® impairs performance in combination with alcohol more
than alcohol alone. Derived from this: Statement on whether a warning for drivers is
JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme [Completed]
Phase III study to compare the preventive effect of recurrent brain infarction and safety of
Aggrenox (combination drug containing sustained-release dipyridamole 200 mg/acetylsalicylic
acid 25 mg) twice daily vs. acetylsalicylic acid 81 mg once daily
Pharmacokinetics of Dipyridamole Administered as Aggrenox® (Dipyridamole Extended Release Plus Aspirin) Capsule Versus Dipyridamole Immediate Release Plus Aspirin Following Alteration of Stomach pH [Completed]
Reports of Suspected Aggrenox (Aspirin / Dipyridamole) Side Effects
Cerebral Haemorrhage (11),
Loss of Consciousness (11),
Decreased Appetite (11),
Gastrooesophageal Reflux Disease (9),
Dementia (8), more >>
Page last updated: 2011-12-09